Merck & Co., Inc. (MRK) has upcoming FDA regulatory milestones for KEYTRUDA QLEX™ and I-DXd. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by Merck & Co., Inc. (MRK).
Over the past two years, Merck & Co., Inc. has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
KEYTRUDA, LITESPARK-012, Doravirine/Islatravir, ENFLONSIA™, I-DXd, KEYNOTE-B96, and MK-8748. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
KEYTRUDA QLEX™ FDA Regulatory Timeline and Events
KEYTRUDA QLEX™ is a drug developed by Merck & Co., Inc. for the following indication: Injection for Subcutaneous Use in Adults Across Most Solid Tumor Indications for KEYTRUDA® (pembrolizumab).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KEYTRUDA QLEX™
- Announced Date:
- April 22, 2026
- Indication:
- Injection for Subcutaneous Use in Adults Across Most Solid Tumor Indications for KEYTRUDA® (pembrolizumab)
Announcement
Labcorp announced the nationwide availability of Agilent Technologies' PD-L1 IHC 22C3 pharmDx, the only companion diagnostic approved by the U.S. Food and Drug Administration (FDA) to identify patients with platinum-resistant ovarian cancer who may be eligible for Merck's KEYTRUDA®.i KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) are the first FDA-approved PD-1 inhibitors available as part of a complete treatment regimen for eligible patients with platinum-resistant ovarian cancer.ii
AI Summary
Labcorp announced nationwide availability of Agilent Technologies’ PD-L1 IHC 22C3 pharmDx, the only FDA-approved companion diagnostic to identify patients with platinum-resistant ovarian cancer who may be eligible for Merck’s KEYTRUDA. The test detects PD-L1 expression in epithelial ovarian, fallopian tube, or primary peritoneal carcinoma and is indicated as an aid in identifying patients for treatment with KEYTRUDA.
KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab with berahyaluronidase alfa-pmph) are the first FDA-approved PD-1 inhibitors available as part of a complete treatment regimen for eligible patients with platinum-resistant ovarian cancer. With nationwide lab access through Labcorp, clinicians can more readily determine PD-L1 status to guide therapy decisions, streamline patient selection, and potentially expand timely access to these approved PD-1 treatment options. Labcorp will perform the assay across its national network of clinical laboratories, offering standardized testing and faster reporting to support oncologists and pathologists in treatment planning.
Read Announcement- Drug:
- KEYTRUDA QLEX™
- Announced Date:
- April 20, 2026
- Target Action Date:
- August 17, 2026
- Indication:
- Injection for Subcutaneous Use in Adults Across Most Solid Tumor Indications for KEYTRUDA® (pembrolizumab)
Announcement
Merck announced that The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date of August 17, 2026.
AI Summary
Merck announced that the U.S. Food and Drug Administration set a Prescription Drug User Fee Act (PDUFA), or target action, date of August 17, 2026. A PDUFA date is the FDA's goal for completing its review and making a decision on a drug application. This date gives Merck, investors, patients and doctors a clear timeline for when a regulatory decision is expected.
By August 17, 2026, the FDA will either approve the application, request more information, or deny approval. The set date helps markets plan and allows stakeholders to prepare for possible changes in treatment options and company outlook. Merck said it is monitoring the review process and will provide updates as needed. Interest will likely grow as the date nears, because the FDA's action could affect Merck's product plans and patient access.
Read Announcement- Drug:
- KEYTRUDA QLEX™
- Announced Date:
- April 20, 2026
- Indication:
- Injection for Subcutaneous Use in Adults Across Most Solid Tumor Indications for KEYTRUDA® (pembrolizumab)
Announcement
Merck announced that the U.S. Food and Drug Administration (FDA) granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA®(pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Merck's anti-PD-1 therapy, each in combination with Padcev® (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy.
AI Summary
Merck announced that the U.S. Food and Drug Administration has granted priority review for two supplemental Biologics License Applications (sBLAs). The filings are for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa‑pmph), each to be used in combination with Padcev® (enfortumab vedotin‑ejfv). Both applications seek approval to treat patients with muscle‑invasive bladder cancer (MIBC) who are eligible for cisplatin‑based chemotherapy.
Priority review signals the FDA will review the applications on an accelerated timeline because the agency believes the treatments could offer a meaningful improvement over existing options. If approved, these combinations could provide additional frontline therapy choices for cisplatin‑eligible MIBC patients. Merck’s announcement highlights the company’s continued development of anti‑PD‑1 therapy options in bladder cancer and its effort to broaden available treatment regimens in this setting.
Read Announcement- Drug:
- KEYTRUDA QLEX™
- Announced Date:
- February 11, 2026
- Indication:
- Injection for Subcutaneous Use in Adults Across Most Solid Tumor Indications for KEYTRUDA® (pembrolizumab)
Announcement
Merck announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) plus paclitaxel, with or without bevacizumab, for the treatment of adults with PD-L1+ (Combined Positive Score [CPS] ≥1), as determined by an FDA-authorized test, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received one or two prior systemic treatment regimens.
AI Summary
Merck announced the U.S. FDA approved KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab with berahyaluronidase alfa‑pmph) given with paclitaxel, with or without bevacizumab, for adults with PD‑L1‑positive (Combined Positive Score ≥1) platinum‑resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. PD‑L1 status must be determined by an FDA‑authorized test.
The approval applies to patients who have received one or two prior systemic treatment regimens. The option combines an anti‑PD‑1 immunotherapy with chemotherapy (paclitaxel) and can be used alongside bevacizumab, an anti‑angiogenic agent. KEYTRUDA QLEX contains a hyaluronidase component intended to aid drug dispersion.
This provides a new, biomarker‑guided treatment choice for a difficult‑to‑treat, platinum‑resistant population. Clinicians will need to use an FDA‑authorized PD‑L1 test to identify eligible patients and consider benefits and risks for each case.
Read Announcement- Drug:
- KEYTRUDA QLEX™
- Announced Date:
- November 19, 2025
- Indication:
- Injection for Subcutaneous Use in Adults Across Most Solid Tumor Indications for KEYTRUDA® (pembrolizumab)
Announcement
Merck announced that the European Commission (EC) has approved a new subcutaneous (SC), or under the skin, route of administration and a new pharmaceutical form (solution for injection) of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy. KEYTRUDA SC™, as it will be marketed in the European Union (EU), [known as KEYTRUDA QLEXTM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], is a subcutaneous injection containing pembrolizumab and berahyaluronidase alfa and has been approved for use across all 33 KEYTRUDA indications for adult patients in Europe.
AI Summary
Merck announced the European Commission has approved a new subcutaneous (under-the-skin) form of KEYTRUDA, to be marketed in the EU as KEYTRUDA SC (known as KEYTRUDA QLEX in the U.S.). The product combines pembrolizumab with berahyaluronidase alfa (developed by Alteogen) and is authorized across all 33 adult KEYTRUDA indications in the 27 EU member states plus Iceland, Liechtenstein and Norway. KEYTRUDA SC is the first and only subcutaneous immune checkpoint inhibitor in Europe and can be administered by a health care provider in as little as one minute, offering dosing options of one minute every three weeks or two minutes every six weeks.
The EC decision was supported by the pivotal Phase 3 3475A-D77 trial in treatment‑naïve metastatic non‑small cell lung cancer, which showed comparable drug exposure for SC and IV KEYTRUDA and similar efficacy outcomes. Overall response rates and measures of progression‑free and overall survival were consistent between the two forms. Commercial availability in each country will depend on national reimbursement processes.
Read Announcement- Drug:
- KEYTRUDA QLEX™
- Announced Date:
- September 19, 2025
- Indication:
- Injection for Subcutaneous Use in Adults Across Most Solid Tumor Indications for KEYTRUDA® (pembrolizumab)
Announcement
Merck announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA QLEX™(pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for KEYTRUDA®(pembrolizumab).
AI Summary
Merck announced that the U.S. Food and Drug Administration has approved KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) for subcutaneous use in adults across most KEYTRUDA solid tumor indications. KEYTRUDA QLEX is the first and only immune checkpoint inhibitor providers can inject under the skin in as little as one minute. It offers two dosing schedules—a one-minute injection every three weeks or a two-minute injection every six weeks—and is expected to be available in late September.
A pivotal Phase 3 trial in metastatic non-small cell lung cancer showed that subcutaneous KEYTRUDA QLEX produced drug exposure and overall response rates similar to intravenous pembrolizumab, with comparable progression-free and overall survival and safety profiles. Subcutaneous administration may simplify treatment, reduce infusion time, and give patients more choices for care settings, from infusion centers to local clinics.
Read Announcement
LITESPARK-012 FDA Regulatory Events
LITESPARK-012 is a drug developed by Merck & Co., Inc. for the following indication: Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LITESPARK-012
- Announced Date:
- April 21, 2026
- Indication:
- Treatments for Certain Patients With Advanced Renal Cell Carcinoma (RCC)
Announcement
Merck announced results from the Phase 3 LITESPARK-012 trial evaluating combination regimens for the first-line treatment of patients with advanced clear cell renal cell carcinoma (RCC).
AI Summary
I don’t have the article text. Please paste the FDA-related article (or a link to it) so I can summarize the Merck LITESPARK-012 Phase 3 results section in about 140 words. I’ll return the summary in HTML paragraph tags at a high-school reading level and will avoid mentioning prior FDA events.
Read Announcement
Doravirine/Islatravir FDA Regulatory Timeline and Events
Doravirine/Islatravir is a drug developed by Merck & Co., Inc. for the following indication: In adults with HIV-1 infection.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Doravirine/Islatravir
- Announced Date:
- April 21, 2026
- Indication:
- In adults with HIV-1 infection
Announcement
Merck announced today that the U.S. Food and Drug Administration (FDA) approved IDVYNSO™, a new, two-drug single-tablet regimen of 100 mg doravirine and 0.25 mg islatravir, for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.
AI Summary
Merck announced FDA approval of IDVYNSO, a once-daily, single-tablet two‑drug regimen containing 100 mg doravirine and 0.25 mg islatravir, for adults to replace their current antiretroviral regimen if they are virologically suppressed (HIV-1 RNA <50 copies/mL), have no history of virologic treatment failure, and have no known substitutions associated with resistance to doravirine.
In Phase 3 trials (Trial 052 vs BIC/FTC/TAF and Trial 051 vs boosted ART), IDVYNSO showed non‑inferior efficacy by Week 48 and had a safety profile generally comparable to the comparator regimens. Discontinuations due to adverse events were low. Common reactions (≥2%) included diarrhea, dizziness, fatigue, abdominal distension, headache, and weight increase.
IDVYNSO is a complete regimen and should not be co‑administered with certain drugs that alter doravirine or islatravir exposure (notably CYP3A inducers, deoxycytidine kinase substrates, or adenosine deaminase inhibitors); clinicians should review concomitant medications and monitor for interactions.Read Announcement
- Drug:
- Doravirine/Islatravir
- Announced Date:
- February 25, 2026
- Indication:
- In adults with HIV-1 infection
Announcement
Merck announced the presentation of results from three pivotal Phase 3 trials evaluating the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir [DOR/ISL (100 mg/0.25 mg), (MK-8591A)] in adults with HIV-1.
AI Summary
Merck announced results from three pivotal Phase 3 trials of an investigational, once-daily, oral two‑drug regimen of doravirine/islatravir (DOR/ISL, 100 mg/0.25 mg; MK‑8591A) in adults with HIV‑1. DOR/ISL is the first non‑INSTI two‑drug regimen to show non‑inferiority and a similar safety profile at Week 48 compared with BIC/FTC/TAF in people starting therapy.
In MK‑8591A‑053, Week 48 virologic suppression was comparable for DOR/ISL versus BIC/FTC/TAF even at high baseline viral loads (>100,000 copies/mL: 94.0% vs 87.6%; >500,000 copies/mL: 90.3% vs 84.4%). Drug‑related adverse events were reported in 14.1% versus 18.0%, and discontinuations due to AEs were 1.1% versus 2.2%; immune reconstitution measures were similar between groups.
In MK‑8591A‑052 and MK‑8591A‑051, DOR/ISL maintained a similar safety profile through Week 96 with no new safety findings. Discontinuation rates were similar (3.2% vs 2.9%), and high rates of virologic suppression were maintained at Week 96 (continued DOR/ISL 92.6%; switched to DOR/ISL 96.6%). Islatravir is an investigational nucleoside analog that inhibits HIV‑1 reverse transcriptase and is being studied as the anchor for two‑drug regimens.
Read Announcement- Drug:
- Doravirine/Islatravir
- Announced Date:
- November 19, 2025
- Indication:
- In adults with HIV-1 infection
Announcement
Merck announced topline results from the pivotal double-blind Phase 3 trial of the investigational, once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir [DOR/ISL (100 mg/0.25 mg)] in adults with HIV-1 infection who had not previously received antiretroviral treatment (treatment-naïve) (MK-8591A-053).
AI Summary
Merck announced topline results from MK-8591A-053, a pivotal double-blind Phase 3 trial testing a once-daily, oral, two-drug single-tablet regimen of doravirine/islatravir (DOR/ISL, 100 mg/0.25 mg) in adults with HIV-1 who had not previously received antiretroviral treatment. The trial was randomized and active-controlled, with 537 participants assigned 1:1 to DOR/ISL or the three-drug comparator bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF).
At Week 48, the primary efficacy endpoint—percentage of participants with HIV-1 RNA <50 copies/mL—met the success criterion: DOR/ISL demonstrated non-inferiority to BIC/FTC/TAF. The primary safety objective was also met, with a comparable safety profile between the regimens. Merck said the data make DOR/ISL the first non-integrase-inhibitor, two-drug regimen to show non-inferior efficacy and safety versus BIC/FTC/TAF in treatment‑naïve adults; the study will continue through Week 144 with additional readouts planned.Read Announcement
- Drug:
- Doravirine/Islatravir
- Announced Date:
- October 15, 2025
- Indication:
- In adults with HIV-1 infection
Announcement
Merck announced today the presentation of additional data from the Phase 3 studies of the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir [DOR/ISL (100mg/0.25mg)] in adults with HIV-1 infection that was virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamidei [BIC/FTC/TAF (50 mg/200 mg/25 mg)] in trial MK-8591A-052 or antiretroviral therapy [baseline antiretroviral therapy (bART)] in trial MK-8591A-051.
AI Summary
Merck announced that additional data from its Phase 3 studies of the investigational two-drug oral regimen DOR/ISL (100 mg/0.25 mg) will be shared at the 20th European AIDS Conference in Paris. In trial MK-8591A-052, adults with suppressed HIV-1 infection who switched from BIC/FTC/TAF to DOR/ISL showed minimal weight and body composition changes at Week 48, matching those who stayed on BIC/FTC/TAF. In both MK-8591A-052 and MK-8591A-051 (where participants switched from their baseline antiretroviral therapy), those on DOR/ISL experienced no clinically meaningful changes in fasting lipids or insulin resistance (HOMA-IR) compared to prior regimens. Experts note these findings are important for people living with HIV, as managing weight, body composition, and cardiovascular risk is a key part of long-term care when switching treatments.
Read Announcement- Drug:
- Doravirine/Islatravir
- Announced Date:
- October 9, 2025
- Indication:
- In adults with HIV-1 infection
Announcement
Merck announced today that it will present new findings from its HIV treatment and prevention pipeline at the 20th European AIDS Conference (EACS 2025) taking place Oct.15-18, 2025, in Paris, France.
AI Summary
Merck announced that at the 20th European AIDS Conference (EACS 2025) Oct. 15–18 in Paris it will present new findings from its HIV treatment and prevention pipeline.
Oral presentations will share 48-week results on weight and body composition from a Phase 3 trial comparing once-daily doravirine/islatravir to a standard three-drug regimen, and 96-week safety and pharmacokinetic data from a Phase 2 study of a weekly oral islatravir-lenacapavir combination.
Poster sessions will highlight fasting lipids and insulin resistance at Week 48 from two Phase 3 studies, and safety and pharmacokinetics of MK-8527—an investigational once-monthly oral PrEP pill—in adults with moderate or severe renal impairment.
These insights reflect Merck’s ongoing efforts to expand options for treating and preventing HIV.
Read Announcement- Drug:
- Doravirine/Islatravir
- Announced Date:
- July 10, 2025
- Indication:
- In adults with HIV-1 infection
Announcement
Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for doravirine/islatravir (DOR/ISL), an investigational, once-daily, oral, two-drug regimen for adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy.
AI Summary
Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for review their New Drug Application (NDA) for doravirine/islatravir (DOR/ISL). This investigational, once-daily, oral two-drug regimen is designed for adults with HIV-1 who are already virologically suppressed on antiretroviral therapy. The application will be reviewed under the Prescription Drug User Fee Act, and the FDA has set a target action date of April 28, 2026.
If approved, DOR/ISL would offer a novel treatment option that could simplify HIV management for patients. Merck believes that this regimen may help address the evolving needs of individuals living with HIV by providing an effective and safe complete treatment option. The company is hopeful that this innovative therapy will make a meaningful difference in the HIV community by complementing existing treatment strategies.
Read Announcement- Drug:
- Doravirine/Islatravir
- Announced Date:
- March 12, 2025
- Indication:
- In adults with HIV-1 infection
Announcement
Merck announced the presentation of positive results from two pivotal Phase 3 trials of the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir [DOR/ISL (100mg/0.25mg)] in adults with HIV-1 infection that is virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamidei [BIC/FTC/TAF (50mg/200mg/25mg)] in trial MK-8591A-052) or antiretroviral therapy [baseline antiretroviral therapy (bART)] in trial MK-8591A-051.
AI Summary
Merck recently announced positive Phase 3 results for its investigational, once-daily two-drug regimen of doravirine/islatravir (DOR/ISL 100 mg/0.25 mg) in treating adults with HIV-1. The studies included trial MK-8591A-052, where participants switched from bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) to DOR/ISL, and trial MK-8591A-051, which evaluated the regimen in patients on baseline antiretroviral therapy. In both trials, DOR/ISL met primary efficacy endpoints by showing non-inferiority to the comparator treatments, with a high percentage of patients maintaining HIV-1 RNA levels below 50 copies/mL at Week 48. The safety profile was also similar between DOR/ISL and the other regimens, suggesting that this new two-drug option could be a promising alternative for people with HIV-1. Merck plans to submit marketing authorization applications by mid-2025.
Read Announcement
ENFLONSIA™ FDA Regulatory Timeline and Events
ENFLONSIA™ is a drug developed by Merck & Co., Inc. for the following indication: In Infants Born During or Entering Their First RSV Season.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ENFLONSIA™
- Announced Date:
- April 17, 2026
- Indication:
- In Infants Born During or Entering Their First RSV Season
Announcement
Merck announced that the European Commission (EC) has approved ENFLONSIA™ (clesrovimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants during their first RSV season.
AI Summary
Merck announced that the European Commission has approved ENFLONSIA™ (clesrovimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season. ENFLONSIA is the first and only RSV preventive option in the European Union that can be given to infants without weight-based dosing, simplifying administration across newborn and infant populations.
In clinical trials the safety profile of ENFLONSIA in infants entering their first RSV season was generally comparable to placebo. The most frequent adverse reactions were injection-site pain (6.5%), injection-site erythema (4.4%), injection-site swelling (3.2%) and rash (2.3%); over 96% of reactions were mild or moderate. When given with routine childhood vaccines, the combined safety profile was similar to giving each separately.
Do not give ENFLONSIA to infants with a history of serious hypersensitivity, including anaphylaxis, to any component. Serious hypersensitivity has been observed with other IgG1 monoclonal antibodies; if reactions occur, initiate appropriate treatment. ENFLONSIA may interfere with some rapid antigen RSV tests; confirm with RT‑PCR when clinical signs suggest RSV but rapid antigen tests are negative.
Read Announcement- Drug:
- ENFLONSIA™
- Announced Date:
- February 19, 2026
- Indication:
- In Infants Born During or Entering Their First RSV Season
Announcement
Merck announced positive second RSV season findings from the Phase 3 SMART trial (MK-1654-007) (NCT04938830) evaluating the safety, efficacy and pharmacokinetics of ENFLONSIA™ (clesrovimab) in infants and children at increased risk for severe respiratory syncytial virus (RSV) disease over two RSV seasons.
AI Summary
Merck reported positive second-season results from the Phase 3 SMART trial (MK-1654-007, NCT04938830) evaluating ENFLONSIA™ (clesrovimab) in infants and children at increased risk for severe respiratory syncytial virus (RSV) disease. The second-season data were presented at the 9th RSV Vaccines and Ventilation Workshop (RSVVW) and will be shared with the U.S. FDA and other global regulators to support an application to expand ENFLONSIA’s indication to protect children through their second RSV season.
ENFLONSIA is a long-acting monoclonal antibody designed to provide direct, rapid and durable protection for about five months with a single, weight-independent dose. Merck noted safety findings consistent with prior reports: serious hypersensitivity is a contraindication, and the most common adverse reactions included injection-site erythema, swelling and rash. Laboratory data suggest ENFLONSIA can interfere with some rapid antigen RSV tests, so PCR confirmation is recommended when clinically appropriate.
Read Announcement- Drug:
- ENFLONSIA™
- Announced Date:
- February 5, 2026
- Indication:
- In Infants Born During or Entering Their First RSV Season
Announcement
Merck announced today that Health Canada has approved ENFLONSIA® (clesrovimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants born during or entering their first RSV season.
AI Summary
Merck announced that Health Canada has approved ENFLONSIA® (clesrovimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season. The approval is supported by Merck’s clinical program, notably the pivotal Phase 2b/3 CLEVER trial (MK‑1654‑004) and the Phase 3 SMART trial (MK‑1654‑007), which showed positive results for the trials’ primary and key secondary endpoints.
Key secondary endpoints included RSV‑associated hospitalization through Day 150 after dosing and RSV‑associated medically attended lower respiratory infection (MALRI) through Day 180 after dosing. The safety profile of clesrovimab was generally comparable to placebo. The most common adverse reaction was injection‑site erythema (4.4% within 5 days), mostly mild to moderate. Injection‑site swelling occurred in 3.2% within 5 days, and rash in 2.3% within 14 days. For full details, consult the ENFLONSIA product monograph.
Read Announcement- Drug:
- ENFLONSIA™
- Announced Date:
- September 19, 2025
- Indication:
- In Infants Born During or Entering Their First RSV Season
Announcement
Merck announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of ENFLONSIA™ (clesrovimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants during their first RSV season.
AI Summary
Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended approval of ENFLONSIA™ (clesrovimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. If approved by the European Commission, ENFLONSIA will be the first and only RSV preventive option in Europe, using the same dose regardless of infant weight. ENFLONSIA is a long-acting monoclonal antibody designed to provide protection for up to five months, matching a typical RSV season.
This recommendation is based on results from the Phase 2b/3 CLEVER trial and the Phase 3 SMART trial, which showed safety and efficacy in preterm, full-term, and high-risk infants. The data were published in the New England Journal of Medicine. ENFLONSIA should not be given to infants with serious hypersensitivity to its components; common adverse effects include injection-site redness, swelling, and rash.
Read Announcement- Drug:
- ENFLONSIA™
- Announced Date:
- June 26, 2025
- Indication:
- In Infants Born During or Entering Their First RSV Season
Announcement
Merck announced the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend ENFLONSIA™ (clesrovimab-cfor) as an option for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in infants younger than 8 months of age who are born during or entering their first RSV season.
AI Summary
Merck announced that the CDC’s Advisory Committee on Immunization Practices (ACIP) has voted to recommend ENFLONSIA™ (clesrovimab-cfor) as an option to help prevent respiratory syncytial virus (RSV) lower respiratory tract disease in infants under 8 months of age. This recommendation targets those born during or entering their first RSV season and is part of the Vaccines for Children Program, ensuring broad access to this new preventive treatment.
ENFLONSIA provides rapid and durable protection for 5 months, the duration of a typical RSV season, and uses a fixed dose regardless of the infant’s weight. The recommendation is provisional and will become final after review by the CDC Director or the Health and Human Services Secretary. Merck plans to begin ordering ENFLONSIA in July 2025, with shipments arriving before the start of the 2025-2026 RSV season.
Read Announcement- Drug:
- ENFLONSIA™
- Announced Date:
- June 9, 2025
- Indication:
- In Infants Born During or Entering Their First RSV Season
Announcement
Merck announced the U.S. Food and Drug Administration (FDA) has approved ENFLONSIA™ (clesrovimab-cfor) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season.
AI Summary
Merck announced that the U.S. Food and Drug Administration approved ENFLONSIA™ (clesrovimab-cfor) for preventing respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants born during or entering their first RSV season. This long-acting monoclonal antibody provides protection for up to five months, which covers a typical RSV season. A key feature of ENFLONSIA is its fixed 105 mg dose that is used regardless of the infant’s weight, simplifying administration. Clinical trial results showed that ENFLONSIA significantly reduced RSV-related lower respiratory infections and hospitalizations, offering a promising option for both healthy and at-risk infants. Merck plans to ensure availability of ENFLONSIA in the U.S. ahead of the upcoming RSV season, aiming to reduce the disease burden on families and health care systems.
Read Announcement
I-DXd FDA Regulatory Timeline and Events
I-DXd is a drug developed by Merck & Co., Inc. for the following indication: In patients with pretreated extensive-stage small cell lung cancer (ES-SCLC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- I-DXd
- Announced Date:
- April 13, 2026
- Target Action Date:
- October 10, 2026
- Indication:
- In patients with pretreated extensive-stage small cell lung cancer (ES-SCLC).
Announcement
Daiichi Sankyo and Merck announced that The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for its regulatory decision, is October 10, 2026.
AI Summary
Daiichi Sankyo and Merck announced that the FDA has set the Prescription Drug User Fee Act (PDUFA) date — the target FDA action date for its regulatory decision — for ifinatamab deruxtecan as October 10, 2026. This date marks when the agency is expected to complete its review of the companies’ application for the investigational therapy for small cell lung cancer (SCLC), based on their clinical program data.
Ifinatamab deruxtecan is a potential first‑in‑class B7‑H3 directed DXd antibody‑drug conjugate discovered by Daiichi Sankyo and co‑developed with Merck. The submission is supported by results from the IDeate‑Lung01 Phase 2 trial and the IDeate‑PanTumor01 Phase 1/2 trial. IDeate‑Lung01 had a randomized dose‑optimization stage (8 vs 12 mg/kg every three weeks) and a 12 mg/kg dose‑expansion stage. The primary endpoint was objective response rate by blinded independent central review per RECIST v1.1; secondary endpoints included duration of response, progression‑free and overall survival, safety, and exploratory intracranial response assessments. B7‑H3 is overexpressed in many cancers, including SCLC, making it a promising target.
Read Announcement- Drug:
- I-DXd
- Announced Date:
- April 13, 2026
- Indication:
- In patients with pretreated extensive-stage small cell lung cancer (ES-SCLC).
Announcement
Daiichi Sankyo and Merck Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd) has been accepted and granted Priority Review by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
AI Summary
The U.S. Food and Drug Administration has accepted the Biologics License Application and granted Priority Review for ifinatamab deruxtecan (I‑DXd) for adult patients with extensive‑stage small cell lung cancer (ES‑SCLC) whose disease progressed on or after platinum‑based chemotherapy. The filing is supported by results from the IDeate‑Lung01 Phase 2 trial and additional data from the IDeate‑PanTumor01 Phase 1/2 program. Ifinatamab deruxtecan is a potential first‑in‑class B7‑H3 directed DXd antibody‑drug conjugate discovered by Daiichi Sankyo and being co‑developed with Merck.
IDeate‑Lung01 included a dose‑optimization stage randomizing patients to 8 or 12 mg/kg IV every three weeks and a dose‑expansion stage at 12 mg/kg. The primary endpoint was objective response rate (ORR) by blinded independent central review per RECIST v1.1; key secondary endpoints included duration of response, progression‑free survival, disease control rate, time to response, overall survival, pharmacokinetics and safety. IDeate‑PanTumor01 evaluated dose‑limiting toxicity and safety in escalation and ORR, durability and other efficacy and biomarker endpoints in expansion.
Read Announcement- Drug:
- I-DXd
- Announced Date:
- September 7, 2025
- Indication:
- In patients with pretreated extensive-stage small cell lung cancer (ES-SCLC).
Announcement
Merck announced Results from the IDeate-Lung01 phase 2 trial showed that ifinatamab deruxtecan (I-DXd) demonstrated clinically meaningful response rates in patients with previously treated extensive-stage small cell lung cancer (ES-SCLC).
AI Summary
Merck announced that ifinatamab deruxtecan showed a 48.2% objective response rate in previously treated extensive-stage small cell lung cancer patients in the IDeate-Lung01 phase 2 trial. Among 137 patients, responses included three complete and 63 partial responses, with stable disease in 54 cases, leading to an overall disease control rate of 87.6%. The median duration of response was 5.3 months, progression-free survival 4.9 months, and overall survival 10.3 months.
In a second-line subset, the confirmed response rate rose to 56.3%, while the third-line and beyond group saw a 45.7% response rate. An exploratory analysis also found a 46.2% intracranial response rate in patients with brain metastases.
The safety profile was consistent with prior data, with 36.5% of patients experiencing grade 3 or higher treatment-related adverse events such as neutropenia and anemia. Discussions with global regulators are now underway. These results underscore its promise for patients with limited options.
Read Announcement- Drug:
- I-DXd
- Announced Date:
- August 18, 2025
- Indication:
- In patients with pretreated extensive-stage small cell lung cancer (ES-SCLC).
Announcement
Daiichi Sankyo and Merck announced that Ifinatamab deruxtecan (I-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.
AI Summary
Daiichi Sankyo and Merck announced that the FDA has granted Breakthrough Therapy Designation (BTD) to ifinatamab deruxtecan (I-DXd) for treating adult patients with extensive-stage small cell lung cancer whose disease progressed after platinum-based chemotherapy. This BTD is intended to speed up development and review of promising treatments that address serious medical needs.
I-DXd is an antibody-drug conjugate that targets B7-H3 and delivers a potent cancer-killing payload directly to tumor cells. It was discovered by Daiichi Sankyo.
The BTD was based on data from the IDeate-Lung01 phase 2 trial, supported by the IDeate-PanTumor01 phase 1/2 study. In IDeate-Lung01, pretreated patients received I-DXd at different dose levels, and the main measure was the objective response rate assessed by an independent central review.
Data from IDeate-Lung01 will be presented in a late-breaking oral session at the IASLC 2025 World Conference on Lung Cancer.
Read Announcement- Drug:
- I-DXd
- Announced Date:
- June 18, 2025
- Indication:
- In patients with pretreated extensive-stage small cell lung cancer (ES-SCLC).
Announcement
Daiichi Sankyo and Merck announced that The first patient has been dosed in the IDeate-Prostate01 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC) with disease progression during or after treatment with an androgen receptor pathway inhibitor.
AI Summary
Daiichi Sankyo and Merck have dosed the first patient in the IDeate-Prostate01 phase 3 trial, which is testing ifinatamab deruxtecan (I-DXd) against standard docetaxel treatment. This trial aims to assess the safety and effectiveness of I-DXd in patients with metastatic castration-resistant prostate cancer (mCRPC) who have experienced disease progression during or after treatment with androgen receptor pathway inhibitors. The study is designed as a multicenter, open-label, randomized trial and will enroll around 1,440 patients globally. With dual primary endpoints of overall survival and radiographic progression-free survival, the trial follows promising phase 1/2 results from previous studies. The focus is on addressing the urgent need for new treatment strategies in mCRPC, offering hope for patients who face limited options after the failure of standard hormonal therapies and chemotherapy.
Read Announcement- Drug:
- I-DXd
- Announced Date:
- May 19, 2025
- Indication:
- In patients with pretreated extensive-stage small cell lung cancer (ES-SCLC).
Announcement
Merck and Daiichi Sankyo announced that The first patient has been dosed in the IDeate-Esophageal01 phase 3 trial evaluating the efficacy and safety of investigational ifinatamab deruxtecan (I-DXd) versus investigator's choice of chemotherapy in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) with disease progression following treatment with a platinum-containing systemic therapy and an immune checkpoint inhibitor.
AI Summary
Merck and Daiichi Sankyo have initiated a pivotal phase 3 trial called IDeate-Esophageal01. The trial evaluates ifinatamab deruxtecan (I-DXd), a potential first-in-class antibody drug conjugate designed to target the B7-H3 protein, against the investigator’s choice of chemotherapy. It is aimed at patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have seen disease progression after treatment with platinum-based chemotherapy and an immune checkpoint inhibitor.
ESCC is an aggressive cancer with limited treatment options after first-line therapy fails. The trial will enroll around 510 patients from Asia, Europe, and North America, with overall survival as the primary endpoint. Early-phase results suggest promising activity with I-DXd, raising hopes for improved outcomes in this challenging patient population.
Read Announcement
KEYNOTE-B96 FDA Regulatory Timeline and Events
KEYNOTE-B96 is a drug developed by Merck & Co., Inc. for the following indication: In Patients With Platinum-Resistant Recurrent Ovarian Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KEYNOTE-B96
- Announced Date:
- April 2, 2026
- Indication:
- In Patients With Platinum-Resistant Recurrent Ovarian Cancer
Announcement
Merck announced that KEYTRUDA® (pembrolizumab), in combination with paclitaxel, with or without bevacizumab, is approved in the European Union (EU) for the treatment of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1 and who have received one or two prior systemic treatment regimens.
AI Summary
Merck announced that KEYTRUDA® (pembrolizumab), given with paclitaxel, with or without bevacizumab, is approved in the European Union for adults with platinum‑resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma. The approval applies to patients whose tumors express PD‑L1 with a Combined Positive Score (CPS) ≥1 and who have received one or two prior systemic treatment regimens.
KEYTRUDA is a PD‑1 immune checkpoint inhibitor. The new EU approval offers a treatment option for people with ovarian‑related cancers that no longer respond to platinum chemotherapy. Using pembrolizumab with paclitaxel — and optionally adding bevacizumab, a blood‑vessel inhibitor — aims to improve outcomes by combining immune therapy with chemotherapy (and targeted therapy when appropriate). The decision expands available therapies for a specific, biomarker‑selected group of patients in the EU.Read Announcement
- Drug:
- KEYNOTE-B96
- Announced Date:
- February 27, 2026
- Indication:
- In Patients With Platinum-Resistant Recurrent Ovarian Cancer
Announcement
Merck announced results from the final analysis of the pivotal Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, showing that KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab significantly improved overall survival (OS), a key secondary endpoint, for patients with platinum-resistant recurrent ovarian cancer regardless of PD-L1 status versus paclitaxel with or without bevacizumab alone, the most active standard of care control arm for patients who are bevacizumab-eligible.
AI Summary
Merck reported final results from the pivotal Phase 3 KEYNOTE-B96 trial (ENGOT-ov65) showing that KEYTRUDA® (pembrolizumab), its anti-PD-1 therapy, combined with chemotherapy (paclitaxel) with or without bevacizumab, significantly improved overall survival (OS) for patients with platinum-resistant recurrent ovarian cancer. The improvement in OS was a key secondary endpoint of the study.
Benefit was seen regardless of PD-L1 status, meaning patients both with and without PD-L1 expression experienced improved survival. The comparison was against paclitaxel with or without bevacizumab alone, which is the most active standard-of-care control for patients who are eligible to receive bevacizumab.
These results suggest adding KEYTRUDA to paclitaxel, with or without bevacizumab, may offer a meaningful survival advantage for this hard-to-treat patient group. Further regulatory and clinical steps are expected to follow.
Read Announcement- Drug:
- KEYNOTE-B96
- Announced Date:
- October 18, 2025
- Indication:
- In Patients With Platinum-Resistant Recurrent Ovarian Cancer
Announcement
Merck announced the first presentation of results from the pivotal Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, evaluating KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab for the treatment of patients with platinum-resistant recurrent ovarian cancer.
AI Summary
Merck announced the first presentation of results from the pivotal Phase 3 KEYNOTE‐B96 trial (ENGOT‐ov65), studying KEYTRUDA® (pembrolizumab) combined with paclitaxel chemotherapy, with or without bevacizumab, in patients with platinum‐resistant recurrent ovarian cancer. This trial is the first immune checkpoint inhibitor regimen in this setting to show a statistically significant overall survival benefit compared to placebo plus chemotherapy ± bevacizumab, both in patients whose tumors express PD‐L1 and in all treated patients.
At the final analysis, the KEYTRUDA‐based combination delivered a clinically meaningful and statistically significant improvement in overall survival versus the control arm. The safety profile was consistent with known effects of KEYTRUDA, and no new safety concerns emerged.
These findings build on earlier positive results for progression‐free survival and will be shared at an upcoming medical meeting.
Read Announcement- Drug:
- KEYNOTE-B96
- Announced Date:
- October 16, 2025
- Indication:
- In Patients With Platinum-Resistant Recurrent Ovarian Cancer
Announcement
Merck announced that the Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its secondary endpoint of overall survival (OS) for the treatment of patients with platinum-resistant recurrent ovarian cancer in all comers.
AI Summary
Merck announced that the Phase 3 KEYNOTE-B96 trial (ENGOT-ov65) met its key secondary endpoint of overall survival (OS) for patients with platinum-resistant recurrent ovarian cancer in all comers. In this study, patients received KEYTRUDA® (pembrolizumab) plus paclitaxel chemotherapy, with or without bevacizumab, and were compared to a placebo plus the same chemotherapy regimen. At the trial’s final analysis, the KEYTRUDA-based arm showed a statistically significant and clinically meaningful OS improvement versus placebo.
KEYNOTE-B96 is the first immune checkpoint inhibitor regimen to demonstrate an OS benefit in this hard-to-treat population, both in patients whose tumors express PD-L1 and in all comers. The safety profile of the combination was consistent with prior studies, with no new safety signals identified. Earlier interim results had already shown benefits in progression-free survival (PFS) and OS for PD-L1 positive patients.
Findings from this final OS analysis will be shared at an upcoming medical meeting, and earlier data will be presented at the ESMO Congress 2025.
Read Announcement- Drug:
- KEYNOTE-B96
- Announced Date:
- May 15, 2025
- Indication:
- In Patients With Platinum-Resistant Recurrent Ovarian Cancer
Announcement
Merck announced that the Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, met its primary endpoint of progression-free survival (PFS) for the treatment of patients with platinum-resistant recurrent ovarian cancer whose tumors expressed PD-L1 and in all comers.
AI Summary
Merck announced that its Phase 3 KEYNOTE-B96 trial (also known as ENGOT-ov65) met its primary endpoint by showing a significant improvement in progression‐free survival (PFS) for patients with platinum‐resistant recurrent ovarian cancer. The study included both patients whose tumors expressed PD-L1 and the full population, highlighting the potential of KEYTRUDA® (pembrolizumab) when used with chemotherapy. The trial also reached a key secondary goal by demonstrating improved overall survival (OS) in patients with PD-L1 positive tumors. This encouraging data suggests that the KEYTRUDA-based regimen, combined with paclitaxel—and in some cases bevacizumab—can offer a valuable treatment option for a challenging form of ovarian cancer. The results support further evaluation and may lead to new treatment strategies, providing hope for patients who have not responded well to traditional platinum-based therapies.
Read Announcement
MK-8748 FDA Regulatory Events
MK-8748 is a drug developed by Merck & Co., Inc. for the following indication: Treatment of Neovascular Age-Related Macular Degeneration.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MK-8748
- Announced Date:
- April 2, 2026
- Indication:
- Treatment of Neovascular Age-Related Macular Degeneration
Announcement
Merck announced the initiation of a pivotal Phase 2b/3 trial evaluating MK-8748 (also known as Tiespectus, EYE201), a novel investigational bispecific antibody that directly activates Tie2 signaling and inhibits vascular endothelial growth factor (VEGF), for the treatment of neovascular (wet) age-related macular degeneration (NVAMD).
AI Summary
Merck announced the start of a pivotal Phase 2b/3 clinical trial of MK-8748 (Tiespectus, EYE201), a new investigational bispecific antibody for treating neovascular (wet) age-related macular degeneration (NVAMD). The trial will test the drug’s effects in people with NVAMD and aims to provide key data on safety and effectiveness.
MK-8748 is designed to both directly activate Tie2 signaling and inhibit vascular endothelial growth factor (VEGF). By targeting these two pathways, the drug seeks to reduce abnormal blood vessel growth and leakage in the eye—processes that drive vision loss in wet AMD. As a bispecific antibody, it can engage two mechanisms with a single molecule, which may affect treatment durability and outcomes.
The Phase 2b/3 study is intended to evaluate dosing, safety, and visual and anatomical outcomes that could support further development and potential regulatory approval if results are positive.
Read Announcement
CORALreef AddOn FDA Regulatory Events
CORALreef AddOn is a drug developed by Merck & Co., Inc. for the following indication: Oral Non-Statin Therapies.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CORALreef AddOn
- Announced Date:
- March 30, 2026
- Indication:
- Oral Non-Statin Therapies
Announcement
Merck announced detailed results from CORALreef AddOn, an active comparator study designed to evaluate the efficacy and safety of enlicitide decanoate compared to other oral non-statin therapies (bempedoic acid, ezetimibe or bempedoic acid with ezetimibe) when added to background statins in adults with hypercholesterolemia who have a history of or are at risk for atherosclerotic cardiovascular disease (ASCVD).
AI Summary
Merck reported detailed results from the Phase 3 CORALreef AddOn trial, an active-comparator study that evaluated enlicitide decanoate versus oral non‑statin therapies (bempedoic acid, ezetimibe, or their combination) when added to background statins in adults with hypercholesterolemia who have a history of or are at risk for atherosclerotic cardiovascular disease (ASCVD).
The safety profile of enlicitide in CORALreef AddOn was consistent with prior CORALreef trials. There were no clinically meaningful differences in adverse event rates across treatment groups. For patients treated with enlicitide, no serious adverse events, no discontinuations due to drug‑related adverse events, and no discontinuations due to drug‑related serious adverse events were reported.
Enlicitide is an investigational oral macrocyclic peptide that inhibits PCSK9 to lower LDL cholesterol, using the same target as injectable PCSK9 inhibitors but as a daily pill. The CORALreef AddOn results support its continued development as a potential oral PCSK9 option for patients on statins.
Read Announcement
Sotatercept-csrk FDA Regulatory Timeline and Events
Sotatercept-csrk is a drug developed by Merck & Co., Inc. for the following indication: In adults with pulmonary arterial hypertension.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- sotatercept-csrk
- Announced Date:
- March 29, 2026
- Indication:
- In adults with pulmonary arterial hypertension
Announcement
Merck today announced detailed results from the Phase 2 CADENCE study, which was designed to evaluate the efficacy, safety and tolerability of two doses (0.3 mg/kg and 0.7 mg/kg) of WINREVAIR™ (sotatercept-csrk) for the treatment of adults with the syndrome of combined post- and precapillary pulmonary hypertension and heart failure with preserved ejection fraction (CpcPH-HFpEF).
AI Summary
Merck announced detailed results from the Phase 2 CADENCE study testing two doses (0.3 mg/kg and 0.7 mg/kg) of WINREVAIR (sotatercept-csrk) in adults with combined post‑ and precapillary pulmonary hypertension and heart failure with preserved ejection fraction (CpcPH‑HFpEF). The study met its primary endpoint, showing a significant reduction in pulmonary vascular resistance (PVR) and improved blood flow from the lungs to the heart.
Merck reported that the totality of evidence—hemodynamic, functional, echocardiographic and clinical measures—supports advancing WINREVAIR into a registrational Phase 3 study for this patient group. The safety profile observed in CpcPH‑HFpEF was generally consistent with the known safety profile of WINREVAIR in pulmonary arterial hypertension (PAH).
Selected safety notes: WINREVAIR may increase hemoglobin and can cause severe erythrocytosis, so hemoglobin should be monitored before each of the first five doses and periodically thereafter. It may harm a fetus, could affect fertility, and is not recommended during breastfeeding; females of reproductive potential should use effective contraception during treatment and for four months after the final dose.
Read Announcement- Drug:
- sotatercept-csrk
- Announced Date:
- March 16, 2026
- Indication:
- In adults with pulmonary arterial hypertension
Announcement
Merck announced new clinical data from the company's cardio-pulmonary pipeline will be presented at the American College of Cardiology's Annual Scientific Session and Expo (ACC.26) in New Orleans, La., from March 28-30.
AI Summary
Merck said it will present new clinical data from its cardio‑pulmonary pipeline at the American College of Cardiology’s Annual Scientific Session (ACC.26) in New Orleans, March 28–30. Two late‑breaking presentations are planned: results from the Phase 3 CORALreef AddOn trial of enlicitide decanoate, an investigational oral PCSK9 inhibitor, and data from the Phase 2 CADENCE trial of WINREVAIR™ (sotatercept‑csrk) in patients with the syndrome of combined post‑ and precapillary pulmonary hypertension and heart failure with preserved ejection fraction (CpcPH‑HFpEF).
Enlicitide is a novel macrocyclic peptide designed to lower LDL cholesterol by blocking PCSK9 and stopping its interaction with LDL receptors, which could increase receptor availability to remove LDL‑C; it has the potential to be the first approved oral PCSK9 therapy. WINREVAIR is being evaluated as an injectable treatment for CpcPH‑HFpEF. These presentations may advance treatment options for cardiovascular and cardiopulmonary diseases and reflect Merck’s focus on cardiometabolic and respiratory research.
Read Announcement- Drug:
- sotatercept-csrk
- Announced Date:
- November 18, 2025
- Indication:
- In adults with pulmonary arterial hypertension
Announcement
Merck announced positive topline results from the Phase 2 CADENCE study evaluating WINREVAIR™ (sotatercept-csrk) in adults for the treatment of combined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF).
AI Summary
Merck reported positive topline results from the Phase 2 CADENCE study of WINREVAIR™ (sotatercept-csrk) in adults with combined post- and precapillary pulmonary hypertension (CpcPH) due to heart failure with preserved ejection fraction (HFpEF). The trial met its primary endpoint: at 24 weeks WINREVAIR produced a statistically significant and clinically meaningful reduction in pulmonary vascular resistance (PVR) versus placebo, which indicates improved blood flow through the lungs to the heart. A preliminary safety assessment was generally consistent with the drug’s known profile.
CADENCE was a randomized, double-blind, placebo-controlled proof-of-concept study that enrolled 164 adults with CpcPH and NYHA class II–III symptoms. Participants were randomized 1:1:1 to placebo, 0.3 mg/kg or 0.7 mg/kg WINREVAIR. The trial included invasive hemodynamics, biomarkers, imaging and exercise testing.
Merck says these data support proof-of-concept and will inform Phase 3 development; the company plans to present the results at a future scientific congress and intends to proceed to Phase 3.
Read Announcement- Drug:
- sotatercept-csrk
- Announced Date:
- October 27, 2025
- Indication:
- In adults with pulmonary arterial hypertension
Announcement
Merck announced that the U.S. Food and Drug Administration (FDA) has approved an update to the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk) for injection, 45mg, 60mg. WINREVAIR, an activin signaling inhibitor, is now FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death.
AI Summary
Merck announced the FDA has approved a label update for WINREVAIR™ (sotatercept-csrk) based on the Phase 3 ZENITH trial. The update expands the treatment of adults with pulmonary arterial hypertension (PAH) to include improving exercise capacity and WHO functional class, and reducing the risk of clinical worsening events like PAH hospitalization, lung transplantation and death.
In ZENITH (172 participants), adding WINREVAIR to background therapy cut the risk of major morbidity and mortality by 76% compared to placebo. Time to first event—death, transplant or hospitalization—occurred in 17% of the WINREVAIR group versus 55% in placebo. The trial ended early because of clear benefit.
Doctors should monitor hemoglobin and platelets before each of the first 5 doses, and periodically after, to manage risks of erythrocytosis, thrombocytopenia or bleeding. WINREVAIR’s most common side effects include infections, nosebleed, diarrhea and telangiectasia.
Read Announcement- Drug:
- sotatercept-csrk
- Announced Date:
- September 30, 2025
- Indication:
- In adults with pulmonary arterial hypertension
Announcement
Merck announced positive results from the Phase 3 HYPERION trial evaluating WINREVAIR™ (sotatercept-csrk) versus placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension (PAH, WHO* Group 1) functional class (FC) II or III at intermediate or high risk of disease progression.
AI Summary
Merck’s Phase 3 HYPERION trial tested WINREVAIR (sotatercept-csrk) plus standard PAH therapy against placebo plus standard therapy in adults diagnosed within one year with pulmonary arterial hypertension (WHO Group 1, functional class II/III) at intermediate or high risk. The study showed WINREVAIR cut the risk of clinical worsening by 76% (HR 0.24; p < 0.0001), using a composite measure of death, PAH-related hospitalization, atrial septostomy, lung transplant, or disease progression.
Benefit appeared within six weeks and lasted over a year, with 10.6% of WINREVAIR patients experiencing worsening events versus 36.9% with placebo. Results were consistent across different PAH causes and risk groups. Most participants (over 70%) were on two background therapies. The safety profile matched prior trials, with similar rates of adverse events in both groups. Findings were shared at ERS 2025 and in the New England Journal of Medicine.
Read Announcement- Drug:
- sotatercept-csrk
- Announced Date:
- July 2, 2025
- Target Action Date:
- October 25, 2025
- Indication:
- In adults with pulmonary arterial hypertension
Announcement
Merck announced that The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of Oct. 25, 2025.
AI Summary
Merck announced that the FDA has accepted and granted priority review for its supplemental Biologics License Application (sBLA) to update the label for WINREVAIR, a treatment for pulmonary arterial hypertension (PAH). The application is based on positive data from the Phase 3 ZENITH trial, which showed a 76% reduction in severe outcomes such as death, lung transplantation, or hospitalization related to PAH. These encouraging results highlight significant benefits for patients who are still at high risk despite background therapy.
A major highlight of this development is that the FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of October 25, 2025. This deadline is a critical milestone in Merck’s effort to bring new treatment options to patients, ensuring a focused review process that addresses a pressing unmet medical need in PAH care.
Read Announcement- Drug:
- sotatercept-csrk
- Announced Date:
- July 2, 2025
- Indication:
- In adults with pulmonary arterial hypertension
Announcement
Merck announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking approval to update the U.S. product label based on the Phase 3 ZENITH trial for WINREVAIR™ (sotatercept-csrk). In 2024, WINREVAIR was approved for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 PH) to increase exercise capacity, improve WHO* functional class (FC), and reduce the risk of clinical worsening events.
AI Summary
Merck announced that the FDA has accepted and granted priority review for its supplemental Biologics License Application (sBLA) to update the U.S. product label for WINREVAIR™ (sotatercept‐csrk). This application is based on the Phase 3 ZENITH trial, which showed that WINREVAIR significantly reduced major clinical worsening events in patients with pulmonary arterial hypertension (PAH). In the ZENITH study, WINREVAIR treatment lowered the risk of events such as all‐cause death, lung transplantation, and prolonged PAH-related hospitalizations.
WINREVAIR was approved in 2024 for treating adults with PAH to improve exercise capacity, enhance WHO functional class, and reduce the risk of clinical events. The FDA’s decision, with a target action date of October 25, 2025, shows confidence in the trial data and supports efforts to provide better treatment options to PAH patients, addressing a significant unmet medical need.
Read Announcement- Drug:
- sotatercept-csrk
- Announced Date:
- June 23, 2025
- Indication:
- In adults with pulmonary arterial hypertension
Announcement
Merck announced positive topline results from the Phase 3 HYPERION study evaluating WINREVAIR™ (sotatercept-csrk) versus placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension (PAH, WHO* Group 1) functional class (FC) II or III at intermediate or high risk of disease progression.
AI Summary
Merck announced positive topline results from its Phase 3 HYPERION study, which evaluated WINREVAIR™ (sotatercept-csrk) in recently diagnosed adults with pulmonary arterial hypertension (PAH) at intermediate or high risk. The study focused on patients with WHO Group 1 PAH in functional class II or III. WINREVAIR, when used in combination with background therapy (with about 72% of patients on double therapy), significantly reduced the risk of clinical worsening events compared to placebo. The primary endpoint measured time to clinical worsening, including events like PAH-related hospitalizations, atrial septostomy, lung transplantation, and other signs of PAH progression. These results support WINREVAIR’s potential as an effective treatment option early in the PAH treatment journey, providing new hope for patients facing this progressive disease.
Read Announcement- Drug:
- sotatercept-csrk
- Announced Date:
- May 16, 2025
- Indication:
- In adults with pulmonary arterial hypertension
Announcement
Merck announced new clinical and outcomes research data on pulmonary arterial hypertension (PAH) to be presented at the American Thoracic Society's (ATS) 2025 International Conference in San Francisco from May 16-21.
AI Summary
Merck announced that it will share new clinical and outcomes research data on pulmonary arterial hypertension (PAH) at the American Thoracic Society (ATS) 2025 International Conference in San Francisco, scheduled from May 16 to 21. The data will be featured in nine sessions and include results from a pooled analysis of key studies – PULSAR, SPECTRA, and STELLAR – along with the ongoing SOTERIA open-label extension study. These presentations will highlight the long-term safety, tolerability, and effectiveness of WINREVAIR™, a treatment designed to improve exercise capacity and reduce the risk of clinical worsening in PAH patients. The results represent the largest analysis of WINREVAIR data to date and underscore Merck’s commitment to advancing research and exploring promising treatment options for those suffering from this challenging and life-threatening condition.
Read Announcement- Drug:
- sotatercept-csrk
- Announced Date:
- March 19, 2025
- Indication:
- In adults with pulmonary arterial hypertension
Announcement
Merck announced that new clinical and outcomes research data will be presented at the American College of Cardiology's Annual Scientific Session and Expo (ACC.25) in Chicago from March 29-31.
AI Summary
Merck announced that new clinical and outcomes research data will be presented at the American College of Cardiology’s Annual Scientific Session and Expo (ACC.25) in Chicago from March 29-31. Most notably, the Phase 3 ZENITH trial data will be shared as a late-breaking oral presentation on March 31. The trial evaluated WINREVAIR™ (sotatercept-csrk) when added to background therapy in adults with pulmonary arterial hypertension (PAH), specifically those in WHO functional classes III or IV who are at high risk of mortality. The study showed overwhelming efficacy, leading to an early conclusion of the interim analysis. This presentation highlights Merck’s commitment to advancing clinical research in cardiovascular treatments and improving outcomes for patients with PAH, while reinforcing the company’s ongoing efforts to develop innovative strategies for managing serious cardiovascular conditions.
Read Announcement- Drug:
- sotatercept-csrk
- Announced Date:
- January 30, 2025
- Indication:
- In adults with pulmonary arterial hypertension
Announcement
Merck announced the Phase 3 HYPERION study evaluating WINREVAIR (sotatercept-csrk) versus placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension (PAH, WHO* Group 1) functional class (FC) II or III at intermediate or high risk of disease progression will be stopped early.
AI Summary
Merck announced that the Phase 3 HYPERION study evaluating WINREVAIR (sotatercept-csrk) versus placebo, both with background therapy, in newly diagnosed pulmonary arterial hypertension patients (functional class II or III) will be stopped early. Interim results from the ZENITH trial, along with the overall positive data from the WINREVAIR clinical program, showed clear benefits of WINREVAIR, leading to a loss of clinical equipoise. This means that the evidence strongly favored WINREVAIR, and continuing the placebo-controlled study was no longer ethical.
In light of these findings, Merck, together with the study’s external steering committee and in discussion with the FDA, decided to allow all participants the opportunity to receive WINREVAIR. This decision underscores WINREVAIR’s potential to improve the treatment landscape for patients with pulmonary arterial hypertension.
Read Announcement
BRAVECTO (fluralaner) FDA Regulatory Events
BRAVECTO (fluralaner) is a drug developed by Merck & Co., Inc. for the following indication: Chews for Dogs.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- BRAVECTO (fluralaner)
- Announced Date:
- March 18, 2026
- Indication:
- Chews for Dogs
Announcement
Merck Animal Health, known as MSD Animal Health outside the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA announced the U.S. Food and Drug Administration (FDA) approved an expanded label for BRAVECTO® QUANTUM (fluralaner for extended-release injectable suspension) in dogs.
AI Summary
Merck Animal Health, known as MSD Animal Health outside the United States and Canada and a division of Merck & Co., announced that the U.S. Food and Drug Administration approved an expanded label for BRAVECTO® QUANTUM (fluralaner for extended‑release injectable suspension) for use in dogs. The new label adds protection specifically against Haemaphysalis longicornis (Asian longhorned tick) and Amblyomma maculatum (Gulf Coast tick).
BRAVECTO QUANTUM is a once‑yearly parasiticide given as a single extended‑release injectable dose of fluralaner. With this approval, a single annual injection is labeled to provide protection against those two tick species for 12 months, offering a simplified option for veterinarians and pet owners in areas where these ticks pose a risk.
BRAVECTO is available in multiple formulations for dogs and cats worldwide and is part of Merck Animal Health’s portfolio of flea and tick products.Read Announcement
GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) FDA Regulatory Events
GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is a drug developed by Merck & Co., Inc. for the following indication: Oropharyngeal and Other Head and Neck Cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
- Announced Date:
- March 17, 2026
- Indication:
- Oropharyngeal and Other Head and Neck Cancers
Announcement
Merck announced it will present new clinical and real-world data reaffirming the long-term effectiveness of the company's 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) and its 4-valent HPV vaccine, GARDASIL® (Human Papillomavirus 4-valent Vaccine, Recombinant) against certain HPV-related cancers and diseases at the EUROGIN International Multidisciplinary HPV Congress 2026 in Vienna, Austria, from March 18-21.
AI Summary
Merck will present new clinical and real-world data at the EUROGIN International Multidisciplinary HPV Congress 2026 in Vienna (March 18–21) reaffirming the long-term effectiveness of its 9-valent vaccine, GARDASIL®9, and its 4-valent vaccine, GARDASIL®, against certain HPV-related cancers and diseases.
Key results include studies in women aged 16–26 showing vaccine effectiveness for at least 14 years after three doses of GARDASIL®9 and up to 18 years after three doses of the quadrivalent GARDASIL® against HPV 16/18-related high-grade cervical disease. Additional analyses strengthen evidence on certain HPV-related oropharyngeal cancers, highlighting the importance of vaccinating both females and males to reduce these cancers.
Merck will also share data on adult- and juvenile-onset recurrent respiratory papillomatosis and other outcomes from studies conducted in the U.S., Denmark, Sweden, and the U.K., providing broader real-world context for long-term protection.
Read Announcement
NUMELVI™ FDA Regulatory Events
NUMELVI™ is a drug developed by Merck & Co., Inc. for the following indication: for the Treatment of Pruritus Associated with Allergic Dermatitis Including Atopic Dermatitis and Treatment of Clinical Manifestations of Atopic Dermatitis in Dogs.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NUMELVI™
- Announced Date:
- February 25, 2026
- Indication:
- for the Treatment of Pruritus Associated with Allergic Dermatitis Including Atopic Dermatitis and Treatment of Clinical Manifestations of Atopic Dermatitis in Dogs
Announcement
Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA announced today the U.S. Food and Drug Administration (FDA) approval of NUMELVI™ (atinvicitinib tablets) – the first and only second-generation Janus kinase (JAK) inhibitor indicated for the control of pruritus associated with allergic dermatitis in dogs six months of age and older.
AI Summary
Merck Animal Health (known as MSD Animal Health outside the United States and Canada), a division of Merck & Co., Inc., Rahway, N.J., announced U.S. Food and Drug Administration approval of NUMELVI™ (atinvicitinib tablets). NUMELVI is the first and only second‑generation Janus kinase (JAK) inhibitor approved in the U.S. for the control of pruritus (itching) associated with allergic dermatitis in dogs six months of age and older. The approval provides a new oral, targeted option for veterinarians treating dogs that suffer from allergy‑related itch.
"Merck Animal Health is proud to introduce NUMELVI, our latest advancement geared at rapidly controlling pruritus associated with allergic dermatitis, a common condition that causes distress for so many pets and pet owners," said Christine McKinney, DVM, DACVD. Merck expects NUMELVI to help veterinarians manage dogs' discomfort and improve quality of life for affected pets and their families.
Read Announcement- Drug:
- NUMELVI™
- Announced Date:
- June 12, 2025
- Indication:
- for the Treatment of Pruritus Associated with Allergic Dermatitis Including Atopic Dermatitis and Treatment of Clinical Manifestations of Atopic Dermatitis in Dogs
Announcement
Merck Animal Health, known as MSD Animal Health outside of the United States and Canada, a division of Merck & Co., Inc., Rahway, N.J., USA announced that the European Medicines Agency's Committee for Veterinary Medicinal Products (CVMP) issued a positive opinion for NUMELVI™ (atinvicitinib) Tablets for Dogs.
AI Summary
Merck Animal Health, known as MSD Animal Health outside the United States and Canada, announced that the European Medicines Agency’s Committee for Veterinary Medicinal Products (CVMP) has given a positive opinion for NUMELVI™ (atinvicitinib) Tablets for Dogs. If approved by the European Commission, NUMELVI will become the first and only second-generation Janus kinase (JAK) inhibitor for treating pruritus linked to allergic and atopic dermatitis in dogs. This once-daily tablet targets JAK1-dependent cytokines that drive itch and inflammation, offering a strong safety profile with over 10-fold selectivity for JAK1 compared to other JAK family members. Importantly, NUMELVI can be used in dogs as young as six months old and shows rapid effectiveness after the first dose without affecting vaccine response. This positive CVMP recommendation is a major step toward offering an innovative treatment to improve the quality of life for dogs suffering from skin conditions.
Read Announcement
KEYTRUDA®(pembrolizumab) FDA Regulatory Timeline and Events
KEYTRUDA®(pembrolizumab) is a drug developed by Merck & Co., Inc. for the following indication: For the treatment of patients with locally advanced or metastatic urothelial carcinoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KEYTRUDA®(pembrolizumab)
- Announced Date:
- February 17, 2026
- Indication:
- For the treatment of patients with locally advanced or metastatic urothelial carcinoma
Announcement
Merck announced that Health Canada has approved KEYTRUDA SC™ (pembrolizumab injection), a new subcutaneous formulation of pembrolizumab, Merck's anti–PD-1 therapy.
AI Summary
Merck announced that Health Canada has approved KEYTRUDA SC™ (pembrolizumab injection), a new subcutaneous formulation of its anti–PD‑1 therapy. The approval allows marketing of the subcutaneous product in Canada; exact commercial availability will depend on provincial and territorial reimbursement decisions and other factors.
The authorization is based on results from pivotal trial 3475A‑D77 in patients with treatment‑naïve metastatic squamous or non‑squamous non‑small cell lung cancer without EGFR, ALK or ROS1 tumor aberrations. In the study, 377 patients were randomized 2:1 to receive either KEYTRUDA SC™ 790 mg subcutaneously every six weeks with platinum‑doublet chemotherapy (n=251) or intravenous pembrolizumab 400 mg every six weeks with the same chemotherapy (n=126). The subcutaneous regimen was shown to be pharmacokinetically noninferior to the intravenous regimen.
KEYTRUDA SC™ contains pembrolizumab, which boosts the immune system by blocking PD‑1, and berahyaluronidase alfa, an enzyme that improves subcutaneous drug delivery.
Read Announcement- Drug:
- KEYTRUDA®(pembrolizumab)
- Announced Date:
- October 9, 2025
- Indication:
- For the treatment of patients with locally advanced or metastatic urothelial carcinoma
Announcement
Merck announced new research from more than 100 abstracts across more than 20 types of cancer and multiple treatment settings from the company's broad and differentiated portfolio and pipeline will be presented at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany, from Oct. 17-21.
AI Summary
Merck announced it will present new research from more than 100 abstracts, covering over 20 cancer types and multiple treatment settings, at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany, from Oct. 17–21. These presentations highlight findings from the company’s broad and differentiated portfolio and pipeline.
Key data includes positive survival results from the Phase 3 KEYNOTE-905/EV-303 and KEYNOTE-B96 studies, selected for discussion during a Presidential Symposium, underscoring the impact of KEYTRUDA (pembrolizumab) in certain bladder and ovarian cancers. These first-time findings showcase the benefit of combining KEYTRUDA with Padcev in muscle-invasive bladder cancer and with chemotherapy in platinum-resistant recurrent ovarian cancer.
Additional highlights include REJOICE-Ovarian01 data on R-DXd for platinum-resistant ovarian cancer, 10-year lung cancer follow-up with KEYTRUDA, and updates on LENVIMA, WELIREG, and novel antibody-drug conjugates. Merck’s goal is to advance treatments across tumor types to improve patient outcomes.
Read Announcement- Drug:
- KEYTRUDA®(pembrolizumab)
- Announced Date:
- September 19, 2025
- Indication:
- For the treatment of patients with locally advanced or metastatic urothelial carcinoma
Announcement
Merck announced that announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted two positive opinions for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy. One recommends approval of a new subcutaneous (SC) route of administration and a new pharmaceutical form (solution for injection) for KEYTRUDA® (pembrolizumab), which if approved would be marketed in the European Union (EU) as KEYTRUDA SC™.
AI Summary
Merck today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted two positive opinions for KEYTRUDA® (pembrolizumab). The first opinion recommends approval of a new subcutaneous (SC) injection form—KEYTRUDA SC™—for all adult KEYTRUDA indications in the European Union (EU). If approved, KEYTRUDA SC could be given under the skin in one minute every three weeks (395 mg) or two minutes every six weeks (790 mg), offering shorter administration time and more flexible treatment locations.
This application was supported by the pivotal 3475A-D77 trial in metastatic non-small cell lung cancer, which showed comparable drug exposure and similar response rates versus intravenous dosing. The second CHMP opinion recommends KEYTRUDA as a perioperative treatment for resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC), based on Phase 3 KEYNOTE-689 results demonstrating improved event-free survival. Final EU decisions are expected in the fourth quarter of 2025.
Read Announcement- Drug:
- KEYTRUDA®(pembrolizumab)
- Announced Date:
- June 13, 2025
- Indication:
- For the treatment of patients with locally advanced or metastatic urothelial carcinoma
Announcement
Merck announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test, as a single agent as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as a single agent.
AI Summary
Merck announced that the U.S. FDA has approved KEYTRUDA® (pembrolizumab) for adult patients with resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (CPS ≥1). This approval marks the first perioperative use of an anti-PD-1 therapy for head and neck cancer. In this new treatment regimen, KEYTRUDA is given as a single agent before surgery (neoadjuvant treatment), then continued after surgery as part of adjuvant therapy combined with radiotherapy—with or without cisplatin—and finally administered alone following radiotherapy.
The decision was supported by data from the Phase 3 KEYNOTE-689 trial, which showed a 30% reduction in the risk of recurrence, progression, or death compared to standard care. This development offers new hope for patients with this challenging form of cancer.
Read Announcement
MK-1084 FDA Regulatory Timeline and Events
MK-1084 is a drug developed by Merck & Co., Inc. for the following indication: Oral selective KRAS G12C inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MK-1084
- Announced Date:
- January 7, 2026
- Indication:
- Oral selective KRAS G12C inhibitor
Announcement
Merck announced the initiation of KANDLELIT-007, a Phase 3 clinical trial evaluating calderasib (MK-1084), an investigational oral selective KRAS G12C inhibitor, in combination with KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) for the first-line treatment of patients with KRAS G12C-mutant, advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).
AI Summary
Merck has started KANDLELIT-007, a global Phase 3 trial testing calderasib (MK-1084), an oral KRAS G12C inhibitor, combined with KEYTRUDA QLEX (subcutaneous pembrolizumab plus berahyaluronidase alfa) as first-line treatment for patients with KRAS G12C‑mutant, advanced or metastatic nonsquamous non‑small cell lung cancer. The randomized, open‑label study will compare daily oral calderasib plus KEYTRUDA QLEX (given every six weeks) against KEYTRUDA QLEX with intravenous pemetrexed and platinum chemotherapy (carboplatin or cisplatin) in newly diagnosed patients. The chemo arm follows standard pemetrexed and platinum scheduling for up to two cycles.
About 675 patients will be enrolled. The primary goal is progression‑free survival in tumors with PD‑L1 expression (TPS ≥1%). Secondary goals include PFS in all patients, overall survival, response rate, duration of response, and safety. Merck says the trial will test whether a chemotherapy‑free, no‑IV combination can improve outcomes and convenience for people with KRAS G12C‑mutant NSCLC. This is the third Phase 3 study in Merck’s KANDLELIT program evaluating calderasib across cancers and settings.
Read Announcement- Drug:
- MK-1084
- Announced Date:
- May 30, 2025
- Indication:
- Oral selective KRAS G12C inhibitor
Announcement
Merck announced today safety and efficacy results from the open-label Phase 1 KANDLELIT-001 study, a clinical trial evaluating MK-1084, an investigational next-generation KRAS G12C inhibitor, alone and in combination with other therapies in certain patients with KRAS G12C-mutant solid tumors, including advanced colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).
AI Summary
Merck reported encouraging safety and efficacy results in the Phase 1 KANDLELIT-001 study of MK-1084, a next-generation KRAS G12C inhibitor. The open-label trial assessed MK-1084 both as a monotherapy and in combination with other therapies in patients with KRAS G12C-mutant solid tumors, including advanced colorectal cancer (CRC) and non-small cell lung cancer (NSCLC). Early data showed that MK-1084 had a manageable safety profile and demonstrated promising antitumor activity in these patient groups. In the trial, MK-1084 was paired with treatments like cetuximab in CRC and KEYTRUDA in NSCLC, with results suggesting potential benefits when used alone or alongside established cancer therapies. Merck is encouraged by these findings and plans to further explore MK-1084’s potential in combination treatments for patients with KRAS mutations.
Read Announcement- Drug:
- MK-1084
- Announced Date:
- May 13, 2025
- Indication:
- Oral selective KRAS G12C inhibitor
Announcement
Merck announced new research across more than 25 types of cancer and multiple treatment settings from the company's broad and differentiated portfolio and pipeline will be showcased at the American Society of Clinical Oncology (ASCO) Annual Meeting (May 30–June 3).
AI Summary
Merck announced it will showcase new research at the ASCO Annual Meeting (May 30–June 3) that spans more than 25 types of cancer and multiple treatment settings. This work highlights the company’s broad and differentiated oncology portfolio and pipeline as it continues to drive innovation in cancer care.
The presentations include first-time data on investigational drugs such as MK-1084, an oral selective KRAS G12C inhibitor studied in patients with advanced colorectal and non‐small cell lung cancers. Additional research will cover novel antibody-drug conjugates and updated analyses with established therapies like KEYTRUDA and WELIREG. These studies underscore Merck’s commitment to developing new treatment approaches to address significant unmet medical needs and expand options for patients across various tumor types.
Read Announcement
EV-304 FDA Regulatory Events
EV-304 is a drug developed by Merck & Co., Inc. for the following indication: in patients with muscle-invasive bladder cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EV-304
- Announced Date:
- December 17, 2025
- Indication:
- in patients with muscle-invasive bladder cancer
Announcement
Merck announced positive topline results from the Phase 3 KEYNOTE-B15 trial (also known as EV-304) in patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy.
AI Summary
Merck reported positive topline results from the Phase 3 KEYNOTE-B15 (EV-304) trial in patients with muscle‑invasive bladder cancer (MIBC) who are eligible for cisplatin. The combination of KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin), given before and after surgery, produced statistically significant and clinically meaningful improvements in event‑free survival (EFS), overall survival (OS) and pathologic complete response (pCR) rates versus standard neoadjuvant chemotherapy (gemcitabine plus cisplatin) followed by surgery.
KEYNOTE‑B15 was an open‑label, randomized Phase 3 study that enrolled 808 cisplatin‑eligible patients. The experimental arm received four neoadjuvant cycles of KEYTRUDA plus enfortumab vedotin, surgery, then adjuvant KEYTRUDA and enfortumab vedotin; the control arm received four cycles of standard neoadjuvant chemotherapy and surgery. The primary endpoint was EFS, with OS and pCR as key secondary endpoints. Safety was consistent with known profiles and no new signals were identified. The trial was conducted with Pfizer and Astellas.
Merck plans to share these results with health authorities and at medical meetings. The finding positions perioperative KEYTRUDA plus an ADC as a promising option to improve survival for cisplatin‑eligible MIBC patients.
Read Announcement
Sotatercept FDA Regulatory Events
Sotatercept is a drug developed by Merck & Co., Inc. for the following indication: Pulmonary Arterial Hypertension (PAH).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Sotatercept
- Announced Date:
- December 12, 2025
- Indication:
- Pulmonary Arterial Hypertension (PAH)
Announcement
Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended the approval of an expanded indication for WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with WHO Functional Class (FC) II, III, and IV based on the Phase 3 ZENITH study.
AI Summary
Merck announced that the European Medicines Agency's CHMP recommended expanding the indication for WINREVAIR™ (sotatercept), when added to other pulmonary arterial hypertension (PAH) therapies, to treat adults with WHO Functional Class II, III and IV PAH. The current EU approval covers adults with WHO FC II–III to improve exercise capacity. The CHMP opinion will be reviewed by the European Commission for amendment of the marketing authorization in the EU, Iceland, Liechtenstein and Norway, with a final decision expected in the first quarter of 2026.
The recommendation is based mainly on the Phase 3 ZENITH trial in 172 high‑risk WHO FC III–IV patients. Adding WINREVAIR reduced the risk of major morbidity and mortality by 76% (HR 0.24; 95% CI 0.13–0.43; p<0.0001); the composite primary endpoint occurred in 17% of treated versus 55% of placebo patients. The trial was stopped early for overwhelming efficacy, and CHMP also considered morbidity and mortality data from the STELLAR trial.
Merck says the broader indication would recognize WINREVAIR’s impact on morbidity and mortality and extend its use to include FC IV patients, aiming to improve access to the activin signaling inhibitor across Europe.
Read Announcement
CAPVAXIVE FDA Regulatory Timeline and Events
CAPVAXIVE is a drug developed by Merck & Co., Inc. for the following indication: For the prevention of invasive disease caused by Streptococcus pneumoniae serotypes.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CAPVAXIVE
- Announced Date:
- December 8, 2025
- Indication:
- For the prevention of invasive disease caused by Streptococcus pneumoniae serotypes
Announcement
Merck announced that the province of Saskatchewan has added CAPVAXIVE®, a 21-valent pneumococcal conjugate vaccine, to its publicly funded adult immunization program.
AI Summary
Merck announced Saskatchewan has added CAPVAXIVE®, a 21-valent pneumococcal conjugate vaccine, to its publicly funded adult immunization program. CAPVAXIVE is approved by Health Canada for adults 18+ to help prevent invasive pneumococcal disease (IPD) — serious infections such as sepsis, meningitis and bacteremic pneumonia — caused by 21 Streptococcus pneumoniae serotypes. The provincial move aims to increase access for eligible adults according to Saskatchewan’s eligibility criteria.
Public Health Agency of Canada surveillance (2019–2023) shows those 21 serotypes accounted for about 65% of IPD in adults 18–49, 74% in adults 50–64, and 80% in adults 65+. These figures reflect circulating serotypes, not vaccine effectiveness. The National Advisory Committee on Immunization supports CAPVAXIVE as an option for adults 65+ and younger adults at increased risk of IPD. Residents should speak with their health care provider or local public health office to confirm eligibility and how to access the vaccine.
Read Announcement- Drug:
- CAPVAXIVE
- Announced Date:
- September 11, 2025
- Indication:
- For the prevention of invasive disease caused by Streptococcus pneumoniae serotypes
Announcement
Merck announced positive results from the Phase 3 STRIDE-13 trial evaluating CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) at the 6th European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Conference on Vaccines, taking place in Lisbon, Portugal.
AI Summary
Merck announced positive results from the Phase 3 STRIDE-13 trial evaluating CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) at the 6th ESCMID Conference on Vaccines in Lisbon, Portugal. The study involved 882 children and adolescents aged 2 to <18 years who had completed routine pneumococcal immunization and had medical conditions that increase their risk for serious pneumococcal disease. Participants were randomly assigned to receive a single dose of CAPVAXIVE or the standard PPSV23 vaccine.
Key findings showed that CAPVAXIVE produced strong immune responses against all 21 pneumococcal serotypes 30 days after vaccination. It was noninferior to PPSV23 for the 12 shared serotypes and superior for the nine unique serotypes in CAPVAXIVE. The rates of overall and serious vaccine-related adverse events were similar between both groups. Merck plans to share these data with global regulatory authorities as part of its effort to provide broader protection against invasive pneumococcal disease in vulnerable youth.
Read Announcement- Drug:
- CAPVAXIVE
- Announced Date:
- March 26, 2025
- Indication:
- For the prevention of invasive disease caused by Streptococcus pneumoniae serotypes
Announcement
Merck announced today that the European Commission (EC) has approved CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older.
AI Summary
Merck announced that the European Commission (EC) has approved CAPVAXIVE®, a pneumococcal 21-valent conjugate vaccine, for use in adults aged 18 and older. The vaccine is designed to actively immunize against invasive disease and pneumonia caused by multiple Streptococcus pneumoniae serotypes, including serotypes 3, 6A, 7F, 8, and many others. The EC approval, based on safety and immunogenicity data from the Phase 3 STRIDE clinical program, authorizes CAPVAXIVE’s marketing in all EU member states, as well as Iceland, Liechtenstein, and Norway. This decision marks an important step in enhancing adult protection against pneumococcal disease, especially for those at high risk due to age or underlying conditions. CAPVAXIVE’s broad coverage targets serotypes responsible for the majority of invasive pneumococcal disease cases, making it a significant advancement in adult immunization.
Read Announcement - Drug:
- CAPVAXIVE
- Announced Date:
- January 31, 2025
- Indication:
- For the prevention of invasive disease caused by Streptococcus pneumoniae serotypes
Announcement
Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.
AI Summary
Merck, known as MSD outside North America, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of CAPVAXIVE™. This 21-valent pneumococcal conjugate vaccine is designed for active immunization of adults 18 years and older to prevent invasive disease and pneumonia caused by Streptococcus pneumoniae. The positive CHMP recommendation is based on strong clinical trial data showing CAPVAXIVE’s potential to protect against serotypes most responsible for severe infections that can lead to hospitalization and even death. Following this recommendation, the European Commission will review the vaccine for marketing authorization in the EU, Iceland, Liechtenstein, and Norway, with a final decision expected by the second quarter of 2025.
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MK-2214 FDA Regulatory Events
MK-2214 is a drug developed by Merck & Co., Inc. for the following indication: , a novel candidate targeting the abnormal accumulation and aggregation of tau in the brain.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MK-2214
- Announced Date:
- December 1, 2025
- Indication:
- , a novel candidate targeting the abnormal accumulation and aggregation of tau in the brain
Announcement
Merck announced plans to present first-in-human data for MK-2214 and MK-1167 at Clinical Trials on Alzheimer's Disease (CTAD) 2025 in San Diego, California from Dec. 1-4.
AI Summary
Merck said it will present first-in-human data for two Alzheimer’s candidates, MK-2214 and MK-1167, at the Clinical Trials on Alzheimer’s Disease (CTAD) 2025 meeting in San Diego, Dec. 1–4. The company will share early clinical results for both agents during poster sessions at the conference.
MK-2214, which targets phosphorylated serine 413 (pS413) tau, was granted Fast Track designation by the U.S. FDA for treating Alzheimer’s disease. Merck will present data from three Phase 1 studies: two single ascending-dose trials in healthy volunteers and one multiple ascending-dose trial in people with mild cognitive impairment or mild-to-moderate Alzheimer’s. Those results helped shape an ongoing Phase 2 trial assessing safety, efficacy and brain changes in early Alzheimer’s disease.
MK-1167 is an oral positive allosteric modulator of the α7 nicotinic receptor. Merck will present first-in-human Phase 1 data that measured effects on prefrontal cortex glutamate metabolism and informed dose selection for its Phase 2 study in people with mild-to-moderate Alzheimer’s on donepezil.
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KEYNOTE-905 FDA Regulatory Events
KEYNOTE-905 is a drug developed by Merck & Co., Inc. for the following indication: Patients with Muscle-Invasive Bladder Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KEYNOTE-905
- Announced Date:
- November 21, 2025
- Indication:
- Patients with Muscle-Invasive Bladder Cancer
Announcement
Merck announced that the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin.
Read Announcement- Drug:
- KEYNOTE-905
- Announced Date:
- October 23, 2025
- Target Action Date:
- April 7, 2026
- Indication:
- Patients with Muscle-Invasive Bladder Cancer
Announcement
Merck announced that The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date of April 7, 2026, marking the first concurrent review of both KEYTRUDA and KEYTRUDA QLEX for the same novel indication.
AI Summary
Merck announced the U.S. Food and Drug Administration has granted priority review for two supplemental Biologics License Applications (sBLAs) for KEYTRUDA and KEYTRUDA QLEX, each given with Padcev, to treat muscle-invasive bladder cancer in patients who cannot take cisplatin chemotherapy. The FDA set a Prescription Drug User Fee Act (PDUFA) date of April 7, 2026, marking the first time both KEYTRUDA and KEYTRUDA QLEX will be reviewed concurrently for the same new use.
These applications are based on Phase 3 KEYNOTE-905 trial data. When used before and after surgery, KEYTRUDA plus Padcev improved event-free survival by 60%, cut the risk of death by 50%, and increased the pathologic complete response rate by 48% compared to surgery alone.
If approved, these regimens would become the first and only perioperative treatments to show a survival benefit in muscle-invasive bladder cancer patients who are ineligible for cisplatin-based therapy.
Read Announcement- Drug:
- KEYNOTE-905
- Announced Date:
- October 23, 2025
- Indication:
- Patients with Muscle-Invasive Bladder Cancer
Announcement
Merck announced that the U.S. Food and Drug Administration (FDA) has granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev® (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.
AI Summary
Merck announced that the U.S. Food and Drug Administration has granted priority review for two supplemental Biologics License Applications (sBLAs) for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab with berahyaluronidase alfa-pmph), each combined with Padcev® (enfortumab vedotin-ejfv). These applications target patients with muscle-invasive bladder cancer who cannot receive cisplatin-based chemotherapy.
The filings are based on Phase 3 KEYNOTE-905 results, which showed that adding KEYTRUDA plus Padcev before and after surgery:
• Improved event-free survival by 60%
• Reduced the risk of death by 50%
• Increased the rate of complete tumor disappearance by 48%
If approved, these regimens would be the first perioperative treatments proven to improve survival in this high-need patient group. The FDA’s Prescription Drug User Fee Act target action date is April 7, 2026.
Read Announcement
EV-303 FDA Regulatory Timeline and Events
EV-303 is a drug developed by Merck & Co., Inc. for the following indication: For Certain Patients with Muscle-Invasive Bladder Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EV-303
- Announced Date:
- November 21, 2025
- Indication:
- For Certain Patients with Muscle-Invasive Bladder Cancer
Announcement
Pfizer Inc and Astellas Pharma Inc announced that the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate (ADC), in combination with the PD-1 inhibitor Keytruda® (pembrolizumab) or Keytruda QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), as neoadjuvant treatment and then continued after cystectomy (surgery) as adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.i
AI Summary
Pfizer and Astellas announced FDA approval of PADCEV (enfortumab vedotin‑ejfv) combined with the PD‑1 inhibitor pembrolizumab (Keytruda) or Keytruda QLEX as neoadjuvant treatment and continued after cystectomy as adjuvant therapy for adults with muscle‑invasive bladder cancer (MIBC) who are ineligible for cisplatin. The approval is based on pivotal Phase 3 EV‑303 (KEYNOTE‑905) results showing a 60% reduction in the risk of disease recurrence, progression, or death (HR=0.40; p<0.0001) and a 50% reduction in risk of death (HR=0.50; p=0.0002) versus surgery alone. Two‑year survival was 79.7% with the combination versus 63.1% with surgery alone, and median outcomes have not been reached for the combination arm.
This is the first antibody‑drug conjugate plus PD‑1 perioperative regimen for cisplatin‑ineligible MIBC and could change standard care. Safety was consistent with known effects: common adverse reactions include rash, peripheral neuropathy, hyperglycemia and lab abnormalities. PADCEV carries a boxed warning for severe, sometimes fatal, skin reactions (including SJS/TEN); clinicians should monitor closely and stop treatment for suspected severe skin toxicity.
Read Announcement- Drug:
- EV-303
- Announced Date:
- October 18, 2025
- Indication:
- For Certain Patients with Muscle-Invasive Bladder Cancer
Announcement
Astellas Pharma Inc. and Pfizer Inc announced positive results from the pivotal Phase 3 EV-303 clinical trial (also known as KEYNOTE-905) for PADCEV™ (enfortumab vedotin), a Nectin-4 directed antibody-drug conjugate, in combination with KEYTRUDA™ (pembrolizumab), a PD-1 inhibitor.
AI Summary
Astellas Pharma and Pfizer reported positive results from the Phase 3 EV-303 (KEYNOTE-905) trial testing PADCEV™ (enfortumab vedotin) with KEYTRUDA™ (pembrolizumab) in patients with muscle-invasive bladder cancer who cannot receive cisplatin. The study looked at using the combination both before (neoadjuvant) and after (adjuvant) surgical removal of the bladder tumor, comparing it to surgery alone.
At the first interim analysis, the PADCEV plus KEYTRUDA group saw a 60% lower risk of tumor recurrence, progression, or death (hazard ratio 0.40; p<0.0001). Two-year event-free survival was 74.7% versus 39.4% with surgery only. Overall survival risk dropped by 50% (hazard ratio 0.50; p<0.0002), with nearly 80% of patients alive at two years compared to 63.1% after surgery alone. Side effects matched known profiles, with itching, hair loss, diarrhea, fatigue, and anemia most common.
Read Announcement- Drug:
- EV-303
- Announced Date:
- September 25, 2025
- Indication:
- For Certain Patients with Muscle-Invasive Bladder Cancer
Announcement
Pfizer Inc will highlight data across its extensive Oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2025, being held October 17-21 in Berlin, Germany. Data from more than 45 company-sponsored, investigator-sponsored, and collaborative research abstracts, including 11 oral/mini oral presentations and five late-breaking sessions, will be presented across Pfizer's core scientific modalities and key tumor areas.
AI Summary
Pfizer Inc. will spotlight data from its extensive oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2025, held October 17–21 in Berlin. The company will present findings from more than 45 company-sponsored, investigator-sponsored, and collaborative abstracts, including 11 oral and mini-oral presentations plus five late-breaking sessions. These cover Pfizer’s core scientific modalities and key tumor areas such as genitourinary, thoracic, breast, and gastrointestinal cancers.
Key highlights include a Presidential Symposium presentation of the Phase 3 EV-303 (KEYNOTE-905) trial evaluating PADCEV® plus KEYTRUDA® in muscle-invasive bladder cancer, which showed unprecedented survival benefits. Pfizer will also report final overall survival results from the Phase 3 EMBARK trial of XTANDI® in non-metastatic hormone-sensitive prostate cancer and updated survival data from the Phase 2 PHAROS study of BRAFTOVI® plus MEKTOVI® in BRAF V600E-mutant non-small cell lung cancer.
By showcasing these late-stage results and emerging pipeline data, Pfizer aims to demonstrate how earlier interventions and innovative therapies can transform patient outcomes and bring new hope to people living with cancer.
Read Announcement- Drug:
- EV-303
- Announced Date:
- August 11, 2025
- Indication:
- For Certain Patients with Muscle-Invasive Bladder Cancer
Announcement
Merck announced positive topline results from the Phase 3 KEYNOTE-905 trial (also known as EV-303) in patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.
AI Summary
Merck today announced positive topline results from the Phase 3 KEYNOTE-905 (EV-303) trial for muscle-invasive bladder cancer (MIBC) patients who cannot receive cisplatin-based chemotherapy. In this study, KEYTRUDA® (pembrolizumab) plus Padcev® (enfortumab vedotin) given before and after surgery significantly improved event-free survival (EFS), the trial’s primary endpoint. The combination also showed meaningful gains in overall survival and pathologic complete response rates, key secondary measures, compared with surgery alone.
This marks the first successful Phase 3 study in cisplatin-ineligible MIBC patients and represents a major step forward for those with high recurrence risk. The safety profile matched known effects of each drug, with no new safety concerns. Merck plans to submit these results to health authorities worldwide and share detailed data at upcoming medical meetings.
Read Announcement
Enlicitide decanoate FDA Regulatory Timeline and Events
Enlicitide decanoate is a drug developed by Merck & Co., Inc. for the following indication: For the Treatment of Adults With Hyperlipidemia.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- enlicitide decanoate
- Announced Date:
- November 9, 2025
- Indication:
- For the Treatment of Adults With Hyperlipidemia
Announcement
Merck announced the first presentation of results from the pivotal Phase 3 CORALreef HeFH trial demonstrating that treatment with enlicitide decanoate, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, resulted in a statistically significant and clinically meaningful reduction in low-density lipoprotein cholesterol (LDL-C) of 59.4% compared to placebo at week 24 (95% CI: -65.6, -53.2; p<0.001) in adults with heterozygous familial hypercholesterolemia (HeFH).
AI Summary
Merck reported pivotal Phase 3 CORALreef HeFH results showing enlicitide decanoate, an investigational once-daily oral PCSK9 inhibitor, cut LDL‑C by 59.4% versus placebo at week 24 (95% CI: -65.6, -53.2; p<0.001) in adults with heterozygous familial hypercholesterolemia (HeFH) on stable statin therapy. The effect was durable, with a 61.5% LDL‑C reduction at one year (95% CI: -69.4, -53.7; p<0.001). At week 24, enlicitide also significantly lowered non‑HDL‑C by 53.0%, ApoB by 49.1%, and Lp(a) by 27.5% versus placebo.
The randomized 2:1 trial enrolled 303 participants (20 mg once daily). Safety and discontinuation rates were similar to placebo (discontinuations 2.0% vs 3.0%), and adherence was high. Sixty‑seven percent of treated patients achieved ≥50% LDL‑C reduction plus LDL‑C <55 mg/dL at week 24 versus 1.0% with placebo. These findings suggest enlicitide may offer strong oral LDL‑C lowering with a placebo‑comparable safety profile for people with HeFH.
Read Announcement- Drug:
- enlicitide decanoate
- Announced Date:
- October 23, 2025
- Indication:
- For the Treatment of Adults With Hyperlipidemia
Announcement
Merck announced plans to present new research from the company's cardio-pulmonary portfolio and pipeline at the American Heart Association (AHA) Scientific Sessions 2025 in New Orleans, La., from November 7–10.
AI Summary
Merck will present new research from its cardio-pulmonary portfolio and pipeline at the American Heart Association (AHA) Scientific Sessions 2025 in New Orleans, November 7–10. The data underline Merck’s dedication to tackling the global burden of cardiovascular and pulmonary diseases.
For the first time, detailed results from the pivotal Phase 3 CORALreef Lipids trial—evaluating the safety and efficacy of enlicitide decanoate, an investigational oral PCSK9 inhibitor—will be shown in adults with hypercholesterolemia and atherosclerotic cardiovascular disease risk. Results from the Phase 3 CORALreef HeFH trial in patients with heterozygous familial hypercholesterolemia will also debut.
In pulmonary arterial hypertension, Merck will present a pooled analysis of the PULSAR, STELLAR and ZENITH trials evaluating mortality and major morbidity outcomes with sotatercept (WINREVAIR™).
On November 9, Merck will hold an investor event alongside AHA to update its cardio-pulmonary strategy, accessible via webcast for analysts, media and the public.
Read Announcement- Drug:
- enlicitide decanoate
- Announced Date:
- September 2, 2025
- Indication:
- For the Treatment of Adults With Hyperlipidemia
Announcement
Merck announced positive topline results from the Phase 3 CORALreef Lipids trial evaluating the safety and efficacy of enlicitide decanoate, an investigational, once-daily oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hypercholesterolemia on a moderate or high intensity statin (or with documented statin intolerance).
AI Summary
Merck announced positive topline results from its Phase 3 CORALreef Lipids trial of enlicitide decanoate. The trial tested safety and efficacy in adults with high cholesterol who were already on moderate or high-intensity statins or had documented statin intolerance. Participants received a once-daily oral dose of this investigational PCSK9 inhibitor.
Results showed that enlicitide decanoate met the study’s primary endpoint by significantly lowering LDL cholesterol compared to placebo. The drug was generally well tolerated, with most adverse events being mild to moderate, and no new safety signals were observed.
Based on these findings, Merck plans to advance enlicitide decanoate toward regulatory review. If approved, it could become a convenient oral option for patients needing extra cholesterol control alongside or instead of statin therapy.
Read Announcement- Drug:
- enlicitide decanoate
- Announced Date:
- June 9, 2025
- Indication:
- For the Treatment of Adults With Hyperlipidemia
Announcement
Merck announced positive topline results from the first two of three Phase 3 clinical trials evaluating the safety and efficacy of enlicitide decanoate, an investigational, oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor being evaluated for the treatment of adults with hyperlipidemia on lipid-lowering therapies, including at least a statin.
AI Summary
Merck recently announced positive topline results from the first two of three Phase 3 clinical trials evaluating enlicitide decanoate. This novel oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor is designed to work alongside lipid-lowering therapies, including at least a statin, for adults with hyperlipidemia. In the CORALreef HeFH and CORALreef AddOn trials, enlicitide showed statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol (LDL-C) compared to placebo and other oral non-statin treatments.
The encouraging results indicate that enlicitide may offer a convenient daily oral option for patients as an alternative to injectable PCSK9 therapies, while maintaining a safety profile similar to comparator treatments. Merck plans to share more detailed data from the Phase 3 program at an upcoming scientific congress.
Read Announcement
KEYNOTE-689 FDA Regulatory Timeline and Events
KEYNOTE-689 is a drug developed by Merck & Co., Inc. for the following indication: In Patients With Resected, Locally Advanced Head and Neck Squamous Cell Carcinoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KEYNOTE-689
- Announced Date:
- October 29, 2025
- Indication:
- In Patients With Resected, Locally Advanced Head and Neck Squamous Cell Carcinoma
Announcement
Merck announced that the European Commission (EC) has approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as monotherapy for the treatment of resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1.
AI Summary
Merck (known as MSD outside North America) announced that the European Commission has approved KEYTRUDA® (pembrolizumab) as a perioperative treatment for adults with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) whose tumors express PD-L1 (Combined Positive Score ≥1). KEYTRUDA will be given as two cycles before surgery (neoadjuvant monotherapy), followed by up to 15 cycles after surgery (adjuvant monotherapy) in combination with radiation therapy, with or without cisplatin.
The approval is based on the Phase 3 KEYNOTE-689 trial, which showed a 30% reduction in the risk of disease recurrence, progression, or death versus radiotherapy alone, and more than doubled median event-free survival (59.7 months versus 29.6 months). This marks the first and only anti-PD-1 option for resectable LA-HNSCC in the European Union. Marketing authorization covers all 27 EU member states, plus Iceland, Liechtenstein and Norway.
Read Announcement- Drug:
- KEYNOTE-689
- Announced Date:
- August 13, 2025
- Indication:
- In Patients With Resected, Locally Advanced Head and Neck Squamous Cell Carcinoma
Announcement
Merck announced today that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumours express PD-L1 (Combined Positive Score [CPS] ≥ 1), as determined by a validated test, as neoadjuvant treatment as monotherapy, continued as adjuvant treatment in combination with radiotherapy (RT) with or without cisplatin and then as monotherapy.
AI Summary
Merck announced that Health Canada has approved KEYTRUDA® (pembrolizumab), its anti-PD-1 therapy, for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score ≥ 1). The regimen includes neoadjuvant monotherapy before surgery, adjuvant treatment with radiotherapy (± cisplatin), followed by KEYTRUDA monotherapy after radiation.
The approval is based on Phase III KEYNOTE-689 results in 714 patients with PD-L1-positive resectable HNSCC. Perioperative pembrolizumab plus adjuvant radiotherapy (with or without cisplatin) reduced the risk of an event affecting event-free survival by 30% versus adjuvant radiotherapy (± cisplatin) alone (HR = 0.70; 95% CI: 0.55–0.89; p = 0.0014).
“Head and neck squamous cell carcinomas present significant treatment challenges,” said André Galarneau, PhD, Executive Director & Vice President, Oncology Business Unit at Merck Canada. “This new perioperative anti-PD-1 option for eligible patients in Canada can make a meaningful difference for their families.”
Read Announcement- Drug:
- KEYNOTE-689
- Announced Date:
- June 18, 2025
- Indication:
- In Patients With Resected, Locally Advanced Head and Neck Squamous Cell Carcinoma
Announcement
CEL-SCI Corporation today applauded the U.S. Food and Drug Administration's (FDA) approval of Merck's KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy, for the treatment of adult patients with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test.
AI Summary
CEL-SCI Corporation applauded the U.S. Food and Drug Administration’s recent approval of Merck’s KEYTRUDA® (pembrolizumab) for treating adult patients with resectable locally advanced head and neck squamous cell carcinoma. This approval applies to tumors that express PD-L1, with a Combined Positive Score (CPS) of 1 or more as determined by an FDA-approved test. The decision, based on interim results from Merck’s Phase 3 KEYNOTE-689 trial, showed a 30% reduction in the risk of recurrence and progression compared to the standard of care.
The approval of KEYTRUDA under a priority review is seen as a positive precedent, suggesting that similar accelerated reviews could be possible for CEL-SCI’s own investigational therapy, Multikine. CEL-SCI views such regulatory momentum as a promising signal for expanding treatment options for head and neck cancer patients.
Read Announcement- Drug:
- KEYNOTE-689
- Announced Date:
- April 27, 2025
- Indication:
- In Patients With Resected, Locally Advanced Head and Neck Squamous Cell Carcinoma
Announcement
Merck announced results from the Phase 3 KEYNOTE-689 trial evaluating KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as a perioperative treatment regimen for patients with stage III or IVA, resected, locally advanced head and neck squamous cell carcinoma (LA-HNSCC).
AI Summary
Merck announced positive Phase 3 KEYNOTE-689 trial results for KEYTRUDA® (pembrolizumab) as a perioperative treatment for patients with stage III or IVA, resected locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The trial evaluated KEYTRUDA both before (neoadjuvant) and after (adjuvant) surgery in combination with standard of care radiotherapy, with or without cisplatin. Findings from the first interim analysis showed that incorporating KEYTRUDA significantly improved event‐free survival compared to standard therapy alone. In patients with a higher PD-L1 combined positive score, the risk of EFS events was reduced by up to 34%, with median EFS extending to nearly 60 months. The safety profile was consistent with previous studies. These promising results mark the first major positive trial in over two decades for resectable LA-HNSCC, offering a potential new treatment option to reduce recurrence and disease progression.
Read Announcement- Drug:
- KEYNOTE-689
- Announced Date:
- February 25, 2025
- Target Action Date:
- June 23, 2025
- Indication:
- In Patients With Resected, Locally Advanced Head and Neck Squamous Cell Carcinoma
Announcement
Merck announced that The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 23, 2025.
AI Summary
Merck recently announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for its anti-PD-1 therapy, KEYTRUDA®, to treat patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC). This treatment plan involves using KEYTRUDA® as a neoadjuvant treatment before surgery and continuing as adjuvant treatment after surgery, alongside standard radiotherapy with or without cisplatin. The application is based on promising interim results from the Phase 3 KEYNOTE-689 trial, which showed significant improvement in event-free survival compared to standard care. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of June 23, 2025, marking the target for a potential decision on the approval of this expanded indication for KEYTRUDA®.
Read Announcement- Drug:
- KEYNOTE-689
- Announced Date:
- February 25, 2025
- Indication:
- In Patients With Resected, Locally Advanced Head and Neck Squamous Cell Carcinoma
Announcement
Merck announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, for the treatment of patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, then continued as adjuvant treatment in combination with standard of care radiotherapy with or without cisplatin and then as a single agent.
AI Summary
Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental Biologics License Application (sBLA) for its anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). The application seeks approval for use in patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC). Under the proposed treatment plan, KEYTRUDA would be given first as neoadjuvant therapy before surgery, then used as adjuvant therapy in combination with standard radiotherapy—with or without cisplatin—and finally continued as a single agent. This application is based on the positive results from the Phase 3 KEYNOTE-689 trial, which demonstrated significant improvement in event-free survival compared to standard care. The FDA has set its target action date as June 23, 2025.
Read Announcement
LEAP-012 FDA Regulatory Events
LEAP-012 is a drug developed by Merck & Co., Inc. for the following indication: Non-Metastatic Hepatocellular Carcinoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LEAP-012
- Announced Date:
- October 29, 2025
- Indication:
- Non-Metastatic Hepatocellular Carcinoma
Announcement
Merck announced results from the Phase 3 LEAP-012 trial evaluating KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, in combination with transarterial chemoembolization (TACE) for the treatment of patients with unresectable, non-metastatic hepatocellular carcinoma (HCC).
AI Summary
Merck and Eisai released results from the Phase 3 LEAP-012 trial testing KEYTRUDA (pembrolizumab) plus LENVIMA (lenvatinib) alongside transarterial chemoembolization (TACE) in patients with unresectable, non-metastatic hepatocellular carcinoma (HCC).
At a planned interim review, the combination did not show a statistically significant improvement in overall survival (OS) compared with TACE alone. The companies judged the chance of meeting the study’s pre-specified OS threshold at a later analysis to be low.
Earlier, the regimen did achieve a significant gain in progression-free survival (PFS) over TACE alone, with consistent PFS benefit seen after additional follow-up.
The safety profile of KEYTRUDA plus LENVIMA with TACE matched what had been observed in earlier LEAP-012 analyses and other studies of the combo.
Based on these findings, the study will close, and investigators will be informed.
Merck and Eisai plan further data analyses and will share detailed results with the scientific community.
Read Announcement
Belzutifan FDA Regulatory Timeline and Events
Belzutifan is a drug developed by Merck & Co., Inc. for the following indication: Treated Patients With Advanced Renal Cell Carcinoma (RCC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- belzutifan
- Announced Date:
- October 28, 2025
- Indication:
- Treated Patients With Advanced Renal Cell Carcinoma (RCC)
Announcement
Merck announced that the Phase 3 LITESPARK-011 trial evaluating the dual oral regimen of WELIREG® (belzutifan), Merck's first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, plus LENVIMA® (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, met one of its primary endpoints of progression-free survival (PFS) for the treatment of patients with advanced renal cell carcinoma (RCC) whose disease progressed on or after treatment with anti-PD-1/L1 therapy.
AI Summary
Merck and Eisai announced that the Phase 3 LITESPARK-011 trial of WELIREG® (belzutifan), a first-in-class oral HIF-2α inhibitor, combined with LENVIMA® (lenvatinib), a multi-targeted VEGF TKI, met its primary endpoint of progression-free survival (PFS) in patients with advanced clear-cell renal cell carcinoma (RCC) whose disease had progressed on or after anti-PD-1/L1 therapy.
At a pre-specified interim analysis, the WELIREG plus LENVIMA combination showed a statistically significant and clinically meaningful PFS improvement versus cabozantinib, and also demonstrated a significant increase in objective response rate (ORR). Although overall survival (OS) trended favorably, it did not reach statistical significance at this analysis; a final OS assessment is planned per protocol.
The safety profiles of both drugs remained consistent with prior studies, and no new safety signals were observed. Merck and Eisai plan to review these data with global regulatory authorities and to present detailed results at an upcoming medical meeting.
These positive findings mark the first successful Phase 3 study pairing a HIF-2α inhibitor with a VEGF-targeted TKI, offering a promising new treatment option for RCC patients after immunotherapy.
Read Announcement- Drug:
- belzutifan
- Announced Date:
- May 14, 2025
- Indication:
- Treated Patients With Advanced Renal Cell Carcinoma (RCC)
Announcement
Merck announced the U.S. Food and Drug Administration (FDA) has approved WELIREG® (belzutifan), Merck's oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL).
AI Summary
Merck recently announced that the FDA has approved WELIREG® (belzutifan) for treating both adults and pediatric patients aged 12 and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma (PPGL). In this setting, PPGL refer to rare tumors that can develop in or outside the adrenal gland, often linked to certain genetic syndromes or mutations. This approval, based on promising results from the LITESPARK-015 trial, marks WELIREG as the only approved oral, non-surgical treatment option available in the U.S. for these complex conditions. Merck’s announcement brings hope to patients who previously had limited systemic treatment choices, underlining the company’s commitment to advancing innovative cancer therapies and improving care for those facing rare and challenging tumors.
Read Announcement- Drug:
- belzutifan
- Announced Date:
- February 18, 2025
- Indication:
- Treated Patients With Advanced Renal Cell Carcinoma (RCC)
Announcement
Merck announced that the European Commission (EC) has conditionally approved WELIREG® (belzutifan), Merck's oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor
AI Summary
Merck announced that the European Commission has conditionally approved WELIREG® (belzutifan), its first and only oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor. The approval covers two indications. The first is for adult patients with von Hippel-Lindau (VHL) disease who need treatment for related tumors—such as renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors—when localized procedures are unsuitable. The second indication is for adult patients with advanced clear cell renal cell carcinoma that has progressed after at least two therapies, including a PD-1/PD-L1 inhibitor and two VEGF targeted treatments. This conditional approval, valid for one year and subject to renewal, is based on positive trial results from LITESPARK-004 and LITESPARK-005. WELIREG is now approved in over 30 countries for treated advanced RCC and more than 40 countries for eligible VHL disease-associated tumors.
Read Announcement
R-DXd FDA Regulatory Events
R-DXd is a drug developed by Merck & Co., Inc. for the following indication: for Patients with CDH6.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- R-DXd
- Announced Date:
- October 19, 2025
- Indication:
- for Patients with CDH6
Announcement
Daiichi Sankyo and Merck announced Results from the phase 2 (dose optimization) part of the REJOICE-Ovarian01 phase 2/3 trial showed that raludotatug deruxtecan (R-DXd) demonstrated clinically meaningful response rates in patients with recurrent platinum-resistant ovarian, primary peritoneal or fallopian tube cancer.
AI Summary
The phase 2 dose-finding portion of the REJOICE-Ovarian01 trial tested raludotatug deruxtecan (R-DXd) in 107 patients with recurrent platinum-resistant ovarian, primary peritoneal or fallopian tube cancer. Data presented at ESMO 2025 showed R-DXd achieved a 50.5% confirmed objective response rate (ORR) across three dose levels (4.8, 5.6 and 6.4 mg/kg), with 3 complete and 51 partial responses. The overall disease control rate was 77.6%.
At the selected 5.6 mg/kg dose (36 patients), the ORR was 50.0% (two complete and 16 partial responses) and the disease control rate reached 80.6%. Tumor responses occurred regardless of CDH6 expression level. Median time to response was about 6.6 weeks for the 5.6 mg/kg group.
Safety findings aligned with earlier studies. The most common side effects included nausea, anemia, asthenia and neutropenia. Based on these results, the 5.6 mg/kg dose will move forward to the phase 3 comparison against standard chemotherapy.
Read Announcement- Drug:
- R-DXd
- Announced Date:
- September 15, 2025
- Indication:
- for Patients with CDH6
Announcement
Merck announced that Raludotatug deruxtecan (R-DXd) has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with bevacizumab.
AI Summary
Merck announced that raludotatug deruxtecan (R-DXd) has received Breakthrough Therapy Designation (BTD) from the FDA for adults with platinum-resistant epithelial ovarian, primary peritoneal, or fallopian tube cancers expressing CDH6 after prior bevacizumab treatment.
R-DXd is a novel antibody-drug conjugate that binds to CDH6 on tumor cells and delivers a targeted chemotherapy payload. It was discovered by Daiichi Sankyo and is being jointly developed with Merck.
The FDA’s BTD program is meant to speed up the development and review of treatments for serious conditions with unmet needs. This designation was granted based on encouraging safety and efficacy signals seen in a phase 1 trial and the ongoing REJOICE-Ovarian01 phase 2/3 trial.
Merck and Daiichi Sankyo plan to present further REJOICE-Ovarian01 data at upcoming medical meetings and will continue working closely with the FDA to bring R-DXd to patients.
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Keytruda (pembrolizumab) + Lenvima (lenvatinib) uHCC FDA Regulatory Events
Keytruda (pembrolizumab) + Lenvima (lenvatinib) uHCC is a drug developed by Merck & Co., Inc. for the following indication: Unresectable Hepatocellular Carcinoma (uHCC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Keytruda (pembrolizumab) + Lenvima (lenvatinib) uHCC
- Announced Date:
- October 18, 2025
- Indication:
- Unresectable Hepatocellular Carcinoma (uHCC)
Announcement
Merck announced long-term follow-up data continued to show durable benefit of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, compared to chemotherapy for patients with advanced endometrial carcinoma following at least one prior platinum-based regimen in any setting.
AI Summary
Merck and Eisai reported five-year follow-up results from the Phase 3 KEYNOTE-775/Study 309 trial in advanced endometrial carcinoma patients. In the mismatch repair proficient (pMMR) subgroup, the combination of KEYTRUDA® (pembrolizumab) and LENVIMA® (lenvatinib) achieved a five-year overall survival (OS) rate of 16.7%, compared to 7.3% with chemotherapy alone. Median OS was 18.0 months versus 12.2 months, reflecting a 30% reduction in the risk of death (HR 0.70).
Results in the all-comers population matched these findings: a 19.9% versus 7.7% five-year OS rate and median OS of 18.7 months versus 11.9 months (HR 0.66). These durable benefits reinforce the long-term value of anti-PD-1 therapy plus a tyrosine kinase inhibitor over standard chemotherapy in this hard-to-treat disease.
No new safety signals emerged after five years, and adverse events were consistent with earlier reports. These data support KEYTRUDA plus LENVIMA as an effective treatment option for patients with advanced endometrial carcinoma following prior platinum-based therapy.
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MK-7240 FDA Regulatory Events
MK-7240 is a drug developed by Merck & Co., Inc. for the following indication: In Inflammatory Bowel Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MK-7240
- Announced Date:
- October 6, 2025
- Indication:
- In Inflammatory Bowel Disease
Announcement
Merck announced it has initiated three Phase 2b trials evaluating the safety and efficacy of tulisokibart (MK-7240), an investigational humanized monoclonal antibody targeting tumor necrosis factor (TNF)-like cytokine 1A (TL1A), in patients with three immune-mediated inflammatory diseases
AI Summary
Merck announced it has started three Phase 2b clinical trials to study tulisokibart (MK-7240) in patients with immune-mediated inflammatory diseases. This investigational antibody targets TL1A, a cytokine linked to inflammation and tissue damage.
The first trial, MK-7240-12, will enroll patients with moderate to severe hidradenitis suppurativa. The second, MK-7240-013, focuses on radiographic axial spondyloarthritis (ankylosing spondylitis). The third, MK-7240-014, will study adults with rheumatoid arthritis.
Global recruitment is underway, aiming to enroll more than 640 patients across all three studies. Each trial will assess the safety and efficacy of different dosing schedules over a defined treatment period.
Tulisokibart is already in Phase 3 testing for ulcerative colitis and Crohn’s disease. Merck’s expansion into these additional diseases reflects its commitment to develop new treatments for patients living with chronic inflammatory conditions.
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HER3-DXd FDA Regulatory Events
HER3-DXd is a drug developed by Merck & Co., Inc. for the following indication: For the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HER3-DXd
- Announced Date:
- August 27, 2025
- Indication:
- For the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC)
Announcement
Merck announced that The first patient has been dosed in the HERTHENA-Breast04 phase 3 trial evaluating the efficacy and safety of investigational patritumab deruxtecan (HER3-DXd) versus investigator's choice of treatment in patients with unresectable locally advanced or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer with disease progression following endocrine and CDK4/6 inhibitor therapy in either the adjuvant or first-line metastatic settings.
AI Summary
Merck and Daiichi Sankyo today announced dosing of the first patient in HERTHENA-Breast04, a global phase 3 trial testing patritumab deruxtecan (HER3-DXd) against investigator’s choice of therapy in adults with unresectable locally advanced or metastatic hormone receptor-positive, HER2-negative breast cancer. Patients must have progressed on endocrine therapy and CDK4/6 inhibitors.
The trial will randomize about 1,000 patients 1:1 to receive patritumab deruxtecan or standard chemotherapy/HER2-directed ADC. Dual primary endpoints are progression-free survival and overall survival, with secondary endpoints including response rate and safety.
Patritumab deruxtecan is an HER3-targeting antibody-drug conjugate developed by Daiichi Sankyo and Merck. Early studies, including ICARUS-Breast01, showed promising anti-tumor activity in heavily pretreated patients, supporting further evaluation.
HERTHENA-Breast04 spans sites across Asia, Europe, North America, and South America. It aims to bring a new treatment option to patients who have limited therapies after progression on current standards.
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VERQUVO (vericiguat) FDA Regulatory Events
VERQUVO (vericiguat) is a drug developed by Merck & Co., Inc. for the following indication: Chronic Heart Failure and Reduced Ejection Fraction.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VERQUVO (vericiguat)
- Announced Date:
- August 25, 2025
- Indication:
- Chronic Heart Failure and Reduced Ejection Fraction
Announcement
Merck announced that new clinical trial and outcomes research data will be presented at the European Society of Cardiology Congress (ESC) 2025 in Madrid, Spain from August 29 – September 1.
AI Summary
Merck announced that it will present new clinical trial and real-world outcomes research at the European Society of Cardiology Congress (ESC) 2025 in Madrid, Spain, from August 29 to September 1. The data cover three serious cardiovascular conditions: atherosclerotic cardiovascular disease (ASCVD), pulmonary hypertension (PH), and heart failure with reduced ejection fraction (HFrEF).
For ASCVD, Merck will deliver two oral presentations examining 10-year registry data on the clinical and economic burden of patients with and without myocardial infarction, and trends in lipid-lowering therapy use. In PH, the company will share the design and rationale of the Phase 2 CADENCE study of WINREVAIR™ (sotatercept-csrk) in combined post- and precapillary PH, plus hemodynamic results from the ZENITH trial in high-risk pulmonary arterial hypertension.
In HFrEF, Merck will feature two hot line oral sessions and two poster presentations on VERQUVO® (vericiguat), including pooled analyses from the VICTOR and VICTORIA trials and real-world practice data. The company will also host three symposia on lipid management, PAH reverse remodeling, and patient advocacy, and sponsor an on-site cardiovascular health screening for attendees.
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KEYNOTE-A18 FDA Regulatory Events
KEYNOTE-A18 is a drug developed by Merck & Co., Inc. for the following indication: For Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KEYNOTE-A18
- Announced Date:
- July 21, 2025
- Indication:
- For Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer
Announcement
Merck announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer.
AI Summary
Merck Canada announced that Health Canada has approved KEYTRUDA® (pembrolizumab) in combination with chemoradiotherapy (CRT) for treating locally advanced FIGO 2014 Stage III-IVA cervical cancer. This marks the first Canadian indication for KEYTRUDA with CRT in this setting. The approval is based on results from the Phase 3 KEYNOTE-A18/ENGOT-cx11/GOG-3047 trial, which showed that adding KEYTRUDA to standard CRT significantly improved both progression-free survival (PFS) and overall survival (OS) compared to CRT alone.
The randomized, double-blind study enrolled more than 1,000 patients. Participants received pembrolizumab alongside cisplatin-based CRT, followed by maintenance pembrolizumab or placebo. In the Stage III-IVA subgroup, pembrolizumab plus CRT reduced the risk of disease progression by 41% (HR 0.59) and the risk of death by 42% (HR 0.58) versus placebo plus CRT.
“This approval adds another therapeutic option for patients in an important disease space,” said Dr. Shannon Salvador, Gynecologic Oncologist and President of the Society of Gynecologic Oncology of Canada. André Galarneau, Vice President at Merck Canada, noted that this milestone underscores the company’s commitment to expanding treatment choices for women with cervical cancer.
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MK-8527 FDA Regulatory Events
MK-8527 is a drug developed by Merck & Co., Inc. for the following indication: novel nucleoside reverse transcriptase translocation inhibitor.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MK-8527
- Announced Date:
- July 14, 2025
- Indication:
- novel nucleoside reverse transcriptase translocation inhibitor
Announcement
Merck announced the initiation of the EXPrESSIVE Phase 3 clinical trials, evaluating the safety and efficacy of MK-8527, an investigational once-monthly, oral nucleoside reverse transcriptase translocation inhibitor (NRTTI) for HIV pre-exposure prophylaxis (PrEP).
AI Summary
Merck has announced the start of the EXPrESSIVE Phase 3 clinical trials to evaluate MK-8527, an investigational once-monthly oral drug developed as a pre-exposure prophylaxis (PrEP) for HIV prevention. MK-8527 is classified as a nucleoside reverse transcriptase translocation inhibitor (NRTTI) and is designed to provide a convenient alternative to daily PrEP medications.
The clinical program includes two major trials. The EXPrESSIVE-11 trial will begin enrolling high-risk individuals in 16 countries in August 2025 to test the safety and efficacy of MK-8527 compared to current HIV prevention methods. Meanwhile, the EXPrESSIVE-10 trial will focus on women and adolescent girls in sub-Saharan Africa and will start enrolling participants in the coming months. Merck’s decision builds on positive Phase 2 results and aims to expand PrEP options globally.
Read Announcement- Drug:
- MK-8527
- Announced Date:
- July 8, 2025
- Indication:
- novel nucleoside reverse transcriptase translocation inhibitor
Announcement
Merck announced that new data from its research pipeline for HIV prevention and treatment will be presented at the 13th International AIDS Society Conference on HIV Science (IAS 2025) taking place July 13-17, 2025, in Kigali, Rwanda. Merck will share new scientific findings from its HIV clinical development programs, including Phase 2 data on the safety and pharmacokinetics of MK-8527, an investigational, novel nucleoside reverse transcriptase translocation inhibitor (NRTTI), dosed orally once monthly, in development for the prevention of HIV as pre-exposure prophylaxis (PrEP).
AI Summary
Merck announced that it will present new findings from its HIV prevention and treatment research at the 13th International AIDS Society Conference on HIV Science (IAS 2025) in Kigali, Rwanda, from July 13-17, 2025. The company will share Phase 2 data on MK-8527, an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) designed as a once-monthly oral pre‐exposure prophylaxis (PrEP) for HIV prevention.
This new data is part of Merck’s growing HIV clinical development program, which aims to offer varied treatment and prevention options, including daily, weekly, and monthly oral regimens. By showcasing its innovative approach at IAS 2025, Merck underlines its commitment to expanding and improving choices for people at risk of HIV infection and those living with HIV.
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V181 FDA Regulatory Events
V181 is a drug developed by Merck & Co., Inc. for the following indication: for the prevention of dengue disease caused by any of the four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- V181
- Announced Date:
- June 12, 2025
- Indication:
- for the prevention of dengue disease caused by any of the four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4)
Announcement
Merck announced the initiation of the MOBILIZE-1 Phase 3 clinical trial evaluating the safety, immunogenicity and efficacy of a single dose of V181, an investigational quadrivalent vaccine, for the prevention of dengue disease caused by any of the four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4), regardless of prior dengue exposure. Recruitment for the trial has begun, and the first participants are now enrolling in Singapore.
AI Summary
Merck has launched the MOBILIZE-1 Phase 3 clinical trial to study V181, an experimental quadrivalent vaccine aimed at preventing dengue disease. The trial will measure the safety, immune response, and effectiveness of a single dose of V181 against all four types of the dengue virus—DENV-1, DENV-2, DENV-3, and DENV-4—no matter if a person has had dengue before or not. With recruitment already underway, the first participants are enrolling in Singapore. This study marks the first Phase 3 trial in Merck's comprehensive clinical program against dengue, a disease that puts nearly half of the world’s population at risk. If the vaccine is successful, it could offer a single-dose option to protect people in dengue-endemic regions and help reduce the serious global burden of this mosquito-borne illness.
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WaveLINE-003 FDA Regulatory Events
WaveLINE-003 is a drug developed by Merck & Co., Inc. for the following indication: In Patients With Relapsed/Refractory DLBCL.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- waveLINE-003
- Announced Date:
- May 30, 2025
- Indication:
- In Patients With Relapsed/Refractory DLBCL
Announcement
Merck announced results from the dose confirmation portion of the Phase 2/3 waveLINE-003 study evaluating zilovertamab vedotin in combination with standard of care rituximab and gemcitabine-oxaliplatin (R-GemOx) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
AI Summary
Merck has announced promising findings from the dose confirmation portion of its Phase 2/3 waveLINE-003 study. The study evaluated zilovertamab vedotin combined with the standard of care regimen—rituximab and gemcitabine-oxaliplatin (R-GemOx)—in patients with relapsed or refractory diffuse large B‐cell lymphoma (DLBCL). Early results indicate that this treatment regimen not only has a manageable safety profile but also shows encouraging antitumor activity in this difficult-to-treat patient population.
The positive outcomes suggest that adding zilovertamab vedotin to R-GemOx may offer a new therapeutic avenue for patients who have not benefited from previous treatments. These findings provide a strong rationale for further clinical investigation, aiming to improve treatment options and overall outcomes for individuals battling aggressive DLBCL.
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KEYNOTE-483 FDA Regulatory Events
KEYNOTE-483 is a drug developed by Merck & Co., Inc. for the following indication: For the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KEYNOTE-483
- Announced Date:
- April 22, 2025
- Indication:
- For the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma.
Announcement
Merck announced that Health Canada has approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
AI Summary
Merck announced that Health Canada has approved KEYTRUDA® (pembrolizumab) in combination with pemetrexed and platinum chemotherapy for treating adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). This is a significant step because it offers a new first-line treatment option for a patient group with very limited choices.
The approval was based on positive results from the Phase 3 IND.227/KEYNOTE-483 trial. The study showed that the combination of KEYTRUDA® with chemotherapy led to statistically significant improvements in overall survival, progression-free survival, and overall response rate compared to chemotherapy alone. Experts believe this new treatment could help improve patient outcomes and provide hope for those battling this aggressive form of cancer.
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MK-3475A-D77 FDA Regulatory Events
MK-3475A-D77 is a drug developed by Merck & Co., Inc. for the following indication: For the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- MK-3475A-D77
- Announced Date:
- March 27, 2025
- Indication:
- For the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC).
Announcement
Merck announced the first data presentation from the pivotal 3475A-D77 Phase 3 trial, evaluating the subcutaneous administration of pembrolizumab, together with berahyaluronidase alfa (MK-3475A; from now on referred to as "subcutaneous pembrolizumab").
AI Summary
Merck announced initial data from its pivotal 3475A-D77 Phase 3 trial that evaluated subcutaneous pembrolizumab administered with berahyaluronidase alfa. In this study, the subcutaneous injection was given every six weeks with a median injection time of two minutes. The trial met its primary endpoints, showing noninferior pharmacokinetics when compared to the standard intravenous KEYTRUDA in patients with metastatic non-small cell lung cancer receiving chemotherapy. Secondary endpoints—including objective response rate, progression-free survival, and duration of response—were consistent between the two administration routes, and overall safety profiles were similar.
Additionally, a time and motion analysis revealed that the subcutaneous method reduced patient chair and treatment room time by nearly 50%, as well as the active treatment time for healthcare professionals. These results suggest that subcutaneous administration could offer both effective treatment and improved efficiency in clinical settings.
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HRS-5346 FDA Regulatory Events
HRS-5346 is a drug developed by Merck & Co., Inc. for the following indication: For Cardiovascular Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- HRS-5346
- Announced Date:
- March 25, 2025
- Indication:
- For Cardiovascular Disease
Announcement
Merck announced that the companies have entered into an exclusive license agreement for HRS-5346, an investigational oral small molecule Lipoprotein(a), or Lp(a), inhibitor currently being evaluated in a Phase 2 clinical trial in China.
AI Summary
Merck and Jiangsu Hengrui Pharmaceuticals have entered into an exclusive license agreement for HRS-5346, an investigational oral small molecule inhibitor designed to lower Lipoprotein(a) levels. HRS-5346 is currently being tested in a Phase 2 clinical trial in China to evaluate its potential in reducing the risk of atherosclerotic cardiovascular disease, a condition linked to high Lp(a) levels found in many adults worldwide.
Under the agreement, Merck will have exclusive rights to develop, manufacture, and commercialize HRS-5346 outside of Greater China. In return, Hengrui Pharma will receive an upfront payment of $200 million, with the possibility of additional milestone payments up to $1.77 billion and royalties on net sales if the drug is approved. Both companies believe this partnership will help accelerate the development of important new treatments for cardiovascular health.
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NRG-GY018 FDA Regulatory Events
NRG-GY018 is a drug developed by Merck & Co., Inc. for the following indication: Evaluating KEYTRUDA in combination with standard of care chemotherapy (paclitaxel and carboplatin).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NRG-GY018
- Announced Date:
- March 19, 2025
- Indication:
- Evaluating KEYTRUDA in combination with standard of care chemotherapy (paclitaxel and carboplatin)
Announcement
Merck announced that Health Canada approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with carboplatin and paclitaxel, followed by KEYTRUDA® as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma.
AI Summary
Merck announced that Health Canada has approved KEYTRUDA® (pembrolizumab) in combination with carboplatin and paclitaxel, followed by KEYTRUDA® alone, for treating adult patients with primary advanced or recurrent endometrial carcinoma. This approval comes from the positive results observed in the Phase 3 KEYNOTE-868/NRG-GY018 trial, which showed that patients treated with the immunotherapy and chemotherapy combination experienced a significant improvement in progression-free survival compared to those receiving a placebo with chemotherapy. The trial demonstrated beneficial outcomes for patients with both deficient and proficient mismatch repair (dMMR and pMMR) profiles, offering new hope for addressing this challenging disease. This decision underscores the potential of immunotherapies to meet the specific needs of women affected by advanced or recurrent endometrial cancer in Canada, marking a significant step forward in treatment options available for this patient population.
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KEYNOTE-671 FDA Regulatory Events
KEYNOTE-671 is a drug developed by Merck & Co., Inc. for the following indication: Evaluating neoadjuvant KEYTRUDA plus chemotherapy.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- KEYNOTE-671
- Announced Date:
- February 11, 2025
- Indication:
- Evaluating neoadjuvant KEYTRUDA plus chemotherapy
Announcement
Merck announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as a treatment for adult patients with resectable Stage II, IIIA, or IIIB (T3-4N2) non-small cell lung carcinoma (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery
AI Summary
Merck announced that Health Canada has approved KEYTRUDA® (pembrolizumab) for treating adult patients with resectable Stage II, IIIA, or IIIB (T3-4N2) non-small cell lung cancer (NSCLC). In this new regimen, KEYTRUDA® is used together with platinum-containing chemotherapy as a neoadjuvant treatment before surgery, and then continued alone as an adjuvant treatment after surgery. This approval was based on positive results from the Phase 3 KEYNOTE-671 trial, which showed statistically significant improvements in event-free survival and overall survival compared to the placebo group. The decision by Health Canada adds a new option for patients with operable NSCLC, highlighting the importance of treating lung cancer at an earlier stage. Merck’s announcement underscores its commitment to expanding effective treatments and improving outcomes for lung cancer patients in Canada.
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LINE-010 FDA Regulatory Events
LINE-010 is a drug developed by Merck & Co., Inc. for the following indication: For the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LINE-010
- Announced Date:
- February 6, 2025
- Indication:
- For the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma
Announcement
Merck announced the initiation of waveLINE-010, a pivotal Phase 3 clinical trial evaluating zilovertamab vedotin in combination with rituximab plus cyclophosphamide, doxorubicin and prednisone (R-CHP) compared to rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) alone, for the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
AI Summary
Merck has announced the start of waveLINE-010, a key Phase 3 clinical trial for patients with previously untreated diffuse large B-cell lymphoma (DLBCL). The study will compare two treatment regimens: one combining Merck’s investigational antibody-drug conjugate zilovertamab vedotin with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP), and the other using the current standard treatment, R-CHOP, which includes vincristine in place of zilovertamab vedotin. The goal of the trial is to determine if adding zilovertamab vedotin can improve patient outcomes, particularly progression-free survival. With global patient recruitment already underway, Merck is looking to build on positive results seen in earlier trials for this aggressive form of non-Hodgkin lymphoma. This trial aligns with Merck’s commitment to developing innovative therapies that meet critical medical needs in hematologic cancers.
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