FDA Events for Merck & Co., Inc. (MRK)
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
belzutifan, CAPVAXIVE, Doravirine/Islatravir, ENFLONSIA™, enlicitide, GARDASIL®9, and HB-200. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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:
- 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- Drug:
- belzutifan
- Announced Date:
- January 27, 2025
- Indication:
- Treated Patients With Advanced Renal Cell Carcinoma (RCC)
Announcement
Merck announced the U.S. Food and Drug Administration (FDA) has accepted for priority review a supplemental new drug application (sNDA) seeking approval of 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 advanced, unresectable, or metastatic pheochromocytoma and paraganglioma (PPGL).
AI Summary
Merck announced that the FDA has accepted its supplemental new drug application for priority review. This application seeks approval for WELIREG® (belzutifan) to treat both adults and children (12 years and older) with advanced pheochromocytoma and paraganglioma (PPGL), which are rare tumors. The decision is based on promising response rates seen in the Phase 2 LITESPARK-015 trial.
If approved, WELIREG would become the only treatment option available in the United States for patients with these advanced tumors. The FDA has set a target action date of May 26, 2025. Merck’s move underlines its commitment to addressing unmet medical needs in rare cancers by potentially offering a new, critical therapy for patients with limited treatment choices.
Read Announcement- Drug:
- belzutifan
- Announced Date:
- December 13, 2024
- Indication:
- Treated Patients With Advanced Renal Cell Carcinoma (RCC)
Announcement
Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the conditional approval of WELIREG® (belzutifan), Merck's oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, as monotherapy
AI Summary
Merck announced that the European Medicines Agency’s CHMP has given a positive opinion for the conditional approval of WELIREG® (belzutifan). This oral hypoxia-inducible factor-2α (HIF-2α) inhibitor is designed to be used as monotherapy for adults with von Hippel-Lindau (VHL) disease who have associated tumors when localized treatments are not appropriate, as well as for adults with advanced clear cell renal cell carcinoma (RCC) that has progressed after receiving multiple prior therapies.
The recommendation is based on promising data from the Phase 2 LITESPARK-004 trial and the Phase 3 LITESPARK-005 trial. The CHMP opinion will now be reviewed by the European Commission, with a final decision expected in early 2025. If approved, WELIREG would become the first and only oral HIF-2α inhibitor available in the European Union.
Read Announcement- Drug:
- belzutifan
- Announced Date:
- November 22, 2024
- Indication:
- Treated Patients With Advanced Renal Cell Carcinoma (RCC)
Announcement
Merck announced that the National Medical Products Administration (NMPA) in China has approved WELIREG® (belzutifan), for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery.
AI Summary
Merck announced that China’s National Medical Products Administration (NMPA) has approved WELIREG® (belzutifan) for treating adult patients with von Hippel-Lindau (VHL) disease. This approval is for patients who need therapy for associated tumors such as renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), provided they do not require immediate surgery. WELIREG is the first and only systemic treatment available in China for these VHL disease-associated tumors and is a first-in-class oral HIF-2α inhibitor. The approval was based on positive results from the Phase 2 LITESPARK-004 trial, which showed encouraging objective response rates and durable responses in patients. This decision marks an important step in providing a non-surgical treatment option for eligible patients with VHL disease in China.
Read Announcement- Drug:
- belzutifan
- Announced Date:
- September 5, 2024
- Indication:
- Treated Patients With Advanced Renal Cell Carcinoma (RCC)
Announcement
Merck announced that it has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for WELIREG® (belzutifan) on August 30th.
AI Summary
Merck recently announced a major milestone in bringing its prescription medicine WELIREG® (belzutifan) to Canadian patients. On August 30th, the company successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA), an organization that negotiates drug prices on behalf of provinces, territories, and federal drug programs. This agreement is a key step towards public reimbursement of WELIREG®, making it more accessible for patients who need treatment.
The successful negotiation with the pCPA highlights a strong collaboration aimed at streamlining the process for new therapies to reach the public. By moving closer to reimbursement, Merck is taking an important step in expanding treatment options for patients suffering from von Hippel-Lindau (VHL) disease, including those with non-metastatic renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors. This progress underscores Merck’s commitment to making innovative treatments available across Canada.
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 approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- 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.
Read Announcement- Drug:
- CAPVAXIVE
- Announced Date:
- June 17, 2024
- Indication:
- For the prevention of invasive disease caused by Streptococcus pneumoniae serotypes
Announcement
Merck MRK, known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine)
AI Summary
Merck MRK, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has approved CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine). This approval marks a significant advancement in active immunization for adults 18 years of age and older. CAPVAXIVE is designed to prevent both invasive disease and pneumonia caused by multiple Streptococcus pneumoniae serotypes, including types responsible for most invasive pneumococcal disease cases in adults.
The vaccine has been developed with a focus on those most at risk, particularly older adults, and has shown robust immune responses in clinical studies. The FDA granted approval following a Priority Review, highlighting the vaccine’s potential to address unmet needs in pneumococcal disease prevention. CAPVAXIVE is intended to offer a new option for protecting adults against serious infections, though it should not be used for individuals with a history of severe allergic reactions to any of its components.
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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:
- 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.
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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:
- 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
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:
- 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.
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GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) - FDA Regulatory Timeline and 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:
- January 8, 2025
- Indication:
- Oropharyngeal and Other Head and Neck Cancers
Announcement
Merck announced that the National Medical Products Administration (NMPA) of China approved GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] for use in males 9-26 years of age to help prevent certain HPV-related cancers and diseases.
AI Summary
Merck announced that the National Medical Products Administration of China has approved GARDASIL®, the Human Papillomavirus Quadrivalent Vaccine, for use in males aged 9 to 26 years. This is the first approval of its kind in China, making it available to help prevent several HPV-related cancers and diseases in young males. The vaccine is designed to protect against anal cancers caused by HPV types 16 and 18, as well as genital warts and precancerous lesions due to HPV types 6, 11, 16, and 18.
This approval represents an important public health milestone in China. Merck hopes that extending the vaccine’s use to a new population will further reduce the burden of HPV-related diseases, building on its previous success in preventing HPV-related conditions in females.
Read Announcement- Drug:
- GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
- Announced Date:
- September 11, 2024
- Indication:
- Oropharyngeal and Other Head and Neck Cancers
Announcement
Merck announced positive top-line results from its pivotal Phase 3 trial (V503-064) evaluating the company's 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) in Japanese males ages 16 to 26 years.
AI Summary
Merck announced positive top-line results from its pivotal Phase 3 trial (V503-064) that evaluated the 9-valent HPV vaccine, GARDASIL®9, in Japanese males aged 16 to 26 years. The trial met both its primary and secondary endpoints, showing that a 3-dose regimen of the vaccine significantly reduced the combined incidence of anogenital persistent infections caused by nine HPV types compared to a placebo. These results support the vaccine's clinical efficacy in preventing persistent HPV infections in this patient group. Merck plans to share the data with regulatory authorities in Japan and other countries to support licensure for use in males. This study adds to the growing evidence of GARDASIL®9’s effectiveness in combating HPV-related cancers and diseases, highlighting the company’s commitment to broadening access and improving public health on a global scale.
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HB-200 + KEYTRUDA (pembrolizumab) - FDA Regulatory Timeline and Events
HB-200 + KEYTRUDA (pembrolizumab) is a drug developed by Merck & Co., Inc. for the following indication: Advanced 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:
- HB-200 + KEYTRUDA (pembrolizumab)
- Announced Date:
- April 25, 2024
- Indication:
- Advanced head and neck cancers
Announcement
HOOKIPA Pharma Inc announced its final pivotal Phase 2/3 trial design for HB-200 in combination with pembrolizumab.
AI Summary
HOOKIPA Pharma Inc. announced its final pivotal Phase 2/3 trial design for HB-200 in combination with pembrolizumab for first-line treatment of patients with HPV16-positive recurrent or metastatic oropharyngeal squamous cell carcinoma (OPSCC). The trial design and protocol have been fully aligned with the FDA’s feedback from a recent Type C meeting, ensuring the study meets necessary regulatory standards.
The seamless Phase 2/3 trial will enroll about 250 patients who will be randomized to receive HB-200 plus pembrolizumab or a placebo plus pembrolizumab. The primary endpoints include objective response rate in Phase 2 and overall survival in Phase 3. Patient enrollment is expected to begin in the fourth quarter of 2024. This focused design based on FDA guidance aims to expedite development and potential registration, advancing HOOKIPA’s path to providing an impactful new treatment option for OPSCC patients.
Read Announcement- Drug:
- HB-200 + KEYTRUDA (pembrolizumab)
- Announced Date:
- April 10, 2024
- Indication:
- Advanced head and neck cancers
Announcement
HOOKIPA Pharma Inc announced that members of HOOKIPA's Executive Team will host an investor call summarizing the Company's constructive regulatory interactions with the U.S.
AI Summary
HOOKIPA Pharma Inc. announced that members of the company’s Executive Team will host an investor call on April 25, 2024, at 8:00 a.m. ET. During the call, the team will summarize HOOKIPA’s positive regulatory discussions with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A key focus of these discussions is the agreement with the FDA on the design and protocol of the upcoming pivotal Phase 2/3 clinical trial. This trial will test HB-200 in combination with pembrolizumab, aiming to meet an unmet need in patients with certain cancers. The call is set to provide investors with more details about the clinical trial plans and the promising regulatory interactions that support the development of HOOKIPA’s innovative immunotherapy programs.
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HER3-DXd - FDA Regulatory Timeline and 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:
- June 26, 2024
- 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 U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of Daiichi Sankyo (TSE: 4568) and Merck's (known as MSD outside of the United States and Canada) (NYSE:MRK) patritumab deruxtecan (HER3-DXd) for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.
AI Summary
The FDA issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of patritumab deruxtecan, a HER3-directed antibody drug conjugate, for adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer who have received two or more systemic therapies. The CRL stems from concerns found during an inspection of a third-party manufacturing facility and is not related to any issues with the efficacy or safety data submitted in the application.
Daiichi Sankyo and Merck, collaborating on the drug, are working closely with the FDA and the manufacturer to address the manufacturing concerns promptly. Both companies remain confident that patritumab deruxtecan will provide a much-needed treatment option for patients with limited alternatives.
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HERTHENA-Lung02 - FDA Regulatory Timeline and Events
HERTHENA-Lung02 is a drug developed by Merck & Co., Inc. for the following indication: In patients with locally advanced or metastaticEGFR-mutated non-small cell lung 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:
- HERTHENA-Lung02
- Announced Date:
- September 17, 2024
- Indication:
- In patients with locally advanced or metastaticEGFR-mutated non-small cell lung cancer
Announcement
Merck announced that The HERTHENA-Lung02 phase 3 trial evaluating patritumab deruxtecan in patients with locally advanced or metastaticEGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement versus platinum plus pemetrexed induction chemotherapy followed by pemetrexed maintenance chemotherapy.
AI Summary
Merck announced new results from the HERTHENA-Lung02 phase 3 trial evaluating patritumab deruxtecan in patients with locally advanced or metastatic EGFR-mutated non‐small cell lung cancer who had already received EGFR TKI treatment. The trial met its primary endpoint by showing a statistically significant improvement in progression-free survival compared to platinum plus pemetrexed induction chemotherapy followed by pemetrexed maintenance therapy. Although the overall survival data are still immature, the significant PFS benefit marks an important step forward for patients with limited options after EGFR TKI failure.
The positive trial results highlight the potential of patritumab deruxtecan as a novel HER3-directed antibody drug conjugate. Merck, together with partner Daiichi Sankyo, is set to initiate discussions with global regulatory authorities to determine the next steps for advancing this promising treatment option.
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HRS-5346 - FDA Regulatory Timeline and 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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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:
- 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- Drug:
- I-DXd
- Announced Date:
- September 7, 2024
- Indication:
- In patients with pretreated extensive-stage small cell lung cancer (ES-SCLC).
Announcement
Merck announced Results from an interim analysis of the dose-optimization part of the ongoing IDeate-Lung01 phase 2 trial showed ifinatamab deruxtecan (I-DXd) continues to demonstrate promising objective response rates in patients with pretreated extensive-stage small cell lung cancer (ES-SCLC).
AI Summary
Recent interim results from the IDeate-Lung01 phase 2 trial showed that ifinatamab deruxtecan, developed by Merck and Daiichi Sankyo, continues to deliver promising outcomes in patients with pretreated extensive-stage small cell lung cancer (ES-SCLC). In the dose-optimization part of the trial, the 12 mg/kg dose achieved an objective response rate of 54.8%, with a majority of patients showing partial responses. This finding supported selecting 12 mg/kg as the optimal dose for further evaluation in both the ongoing trial extension and a newly initiated phase 3 study. Merck highlighted that these substantial response rates in a difficult-to-treat patient population underscore the potential of targeting the B7-H3 protein with ifinatamab deruxtecan. The results provide hope for improved treatment options for patients who have few alternatives and face rapid disease progression.
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KEYFORM-007 - FDA Regulatory Timeline and Events
KEYFORM-007 is a drug developed by Merck & Co., Inc. for the following indication: For Patients With Previously Treated PD-L1 Positive Microsatellite Stable Metastatic Colorectal 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:
- KEYFORM-007
- Announced Date:
- September 25, 2024
- Indication:
- For Patients With Previously Treated PD-L1 Positive Microsatellite Stable Metastatic Colorectal Cancer
Announcement
Merck announced that the Phase 3 KEYFORM-007 trial evaluating the investigational fixed-dose combination of favezelimab, Merck's anti-LAG-3 antibody, and pembrolizumab (KEYTRUDA®), Merck's anti-PD-1 therapy, did not meet its primary endpoint of overall survival (OS) for the treatment of patients with previously treated PD-L1 positive microsatellite stable (MSS) metastatic colorectal cancer (mCRC).
AI Summary
Merck announced that its Phase 3 KEYFORM-007 trial did not meet the primary endpoint of overall survival (OS) in patients with previously treated PD-L1 positive microsatellite stable metastatic colorectal cancer. The study evaluated a fixed-dose combination of favezelimab, Merck’s anti-LAG-3 antibody, and pembrolizumab (KEYTRUDA®), Merck’s anti-PD-1 therapy, compared to standard care drugs regorafenib or TAS-102. The trial results showed no improvement in OS with the combination treatment. However, the safety profile of the fixed-dose regimen was consistent with previous studies, and no new safety signals were observed. Merck is continuing its evaluation of the trial data and will work with investigators to share the findings with the scientific community as they search for better treatment options for patients with metastatic colorectal cancer.
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KEYFORM-008 - FDA Regulatory Timeline and Events
KEYFORM-008 is a drug developed by Merck & Co., Inc. for the following indication: For PD-1 relapsed or refractory classical Hodgkin 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:
- KEYFORM-008
- Announced Date:
- December 16, 2024
- Indication:
- For PD-1 relapsed or refractory classical Hodgkin lymphoma.
Announcement
Merck announced the discontinuation of the clinical development programs for vibostolimab, an anti-TIGIT antibody, and favezelimab, an anti-LAG-3 antibody.
AI Summary
Merck announced that it is stopping clinical development for two investigational antibodies—vibostolimab, an anti‑TIGIT antibody, and favezelimab, an anti‑LAG‑3 antibody. Vibostolimab was being tested in combination with pembrolizumab in Phase 3 KeyVibe trials for non‑small cell lung cancer. The trials met planned futility criteria for overall survival, and an independent Data Monitoring Committee recommended discontinuation. As a result, Merck will also cancel other vibostolimab programs.
Additionally, Merck decided to end the clinical program for favezelimab and will stop enrolling new patients in the KEYFORM‑008 trial, which was assessing the drug with pembrolizumab for classical Hodgkin lymphoma. Patients already enrolled will continue therapy until the study is complete. This decision allows Merck to focus on other promising areas in its diverse oncology pipeline.
Read Announcement
KEYLYNK-001 - FDA Regulatory Timeline and Events
KEYLYNK-001 is a drug developed by Merck & Co., Inc. for the following indication: For people with BRCA non-mutated advanced epithelial 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:
- KEYLYNK-001
- Announced Date:
- December 9, 2024
- Indication:
- For people with BRCA non-mutated advanced epithelial ovarian cancer
Announcement
Merck announced that the Phase 3 KEYLYNK-001 trial evaluating KEYTRUDA® (pembrolizumab) plus chemotherapy followed by maintenance with LYNPARZA® (olaparib), with or without bevacizumab, as a first-line treatment for people with BRCA non-mutated advanced epithelial ovarian cancer met its primary endpoint of progression-free survival (PFS).
AI Summary
Merck announced that the Phase 3 KEYLYNK‑001 trial met its primary endpoint of improving progression‑free survival (PFS) in patients with BRCA non‑mutated advanced epithelial ovarian cancer. In the trial, patients received KEYTRUDA® (pembrolizumab) plus chemotherapy, followed by maintenance with LYNPARZA® (olaparib), with or without bevacizumab, compared to chemotherapy alone. This finding demonstrates a statistically significant and clinically relevant benefit in delaying disease progression for these patients.
Although the study did not reach its secondary endpoint of overall survival, the safety results for both KEYTRUDA and LYNPARZA were in line with previous data. Merck plans to present these results at an upcoming medical meeting and will discuss the findings with regulatory authorities as they continue to explore new treatment options for ovarian cancer.
Read Announcement
KEYLYNK-006 - FDA Regulatory Timeline and Events
KEYLYNK-006 is a drug developed by Merck & Co., Inc. for the following indication: For the first-line treatment of certain patients with metastatic nonsquamous 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:
- KEYLYNK-006
- Announced Date:
- September 15, 2024
- Indication:
- For the first-line treatment of certain patients with metastatic nonsquamous non-small cell lung cancer (NSCLC).
Announcement
Merck announced long-term overall survival (OS) data from the pivotal Phase 3 KEYNOTE-006 trial, evaluating KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in patients with advanced melanoma. Based on 10 years of follow-up, the data showed sustained improved survival outcomes for patients receiving KEYTRUDA as a single agent compared to ipilimumab in patients with advanced melanoma.
AI Summary
Merck announced long-term overall survival data from the pivotal Phase 3 KEYNOTE-006 trial, which evaluated KEYTRUDA® (pembrolizumab) as a single treatment for advanced melanoma. With 10 years of follow-up, the study showed that 34.0% of patients treated with KEYTRUDA were still alive, compared to 23.6% of those who received ipilimumab. This indicates a sustained survival benefit over time.
KEYTRUDA reduced the risk of death by 29% and more than doubled the median overall survival from 15.9 months with ipilimumab to 32.7 months with KEYTRUDA. These results underscore KEYTRUDA’s potential as an effective long-term treatment for patients with advanced melanoma, demonstrating its ability to provide prolonged survival benefits in this patient population.
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KEYNOTE-483 - FDA Regulatory Timeline and 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 approved 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.
Read Announcement- Drug:
- KEYNOTE-483
- Announced Date:
- November 15, 2024
- Indication:
- For the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma.
Announcement
Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of 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 non-epithelioid malignant pleural mesothelioma (MPM).
AI Summary
Merck announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for KEYTRUDA® (pembrolizumab) when combined with pemetrexed and platinum chemotherapy. This treatment is aimed at adult patients with unresectable non-epithelioid malignant pleural mesothelioma (MPM). The decision is based on promising overall survival improvements seen in the pivotal IND.227/KEYNOTE-483 trial, where the combination significantly outperformed chemotherapy alone. Dr. Gregory Lubiniecki emphasized that this marks an important milestone for patients with this more aggressive form of mesothelioma. The recommendation now moves to the European Commission for final marketing authorization, with a decision expected in the fourth quarter of 2024. This development highlights Merck’s commitment to advancing new and effective treatment options for hard-to-treat cancers in Europe.
Read Announcement- Drug:
- KEYNOTE-483
- Announced Date:
- September 18, 2024
- Indication:
- For the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma.
Announcement
Merck announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, 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 the U.S. FDA has approved KEYTRUDA, its anti-PD-1 therapy, in combination with pemetrexed and platinum chemotherapy for first‐line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM). This approval marks the first indication for KEYTRUDA in MPM in the United States. The decision was supported by the Phase 3 IND.227/KEYNOTE-483 trial, which showed that the combination therapy significantly improved overall survival compared to chemotherapy alone. Patients receiving KEYTRUDA with pemetrexed and platinum experienced a meaningful reduction in the risk of death and improved treatment outcomes, offering a new option for a form of cancer that traditionally has a poor prognosis. This milestone underlines Merck’s commitment to advancing oncology research and providing innovative treatment solutions for challenging cancers.
Read Announcement- Drug:
- KEYNOTE-483
- Announced Date:
- May 29, 2024
- Estimated Event Date Range:
- September 25, 2024 - September 25, 2024
- Target Action Date:
- September 25, 2024
- Indication:
- For the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma.
Announcement
Merck announced that The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of September 25, 2024.
AI Summary
Merck announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for KEYTRUDA in combination with chemotherapy to treat patients with unresectable or metastatic malignant pleural mesothelioma. Importantly, the FDA has set a Prescription Drug User Fee Act (PDUFA) or target action date of September 25, 2024. This priority review decision accelerates the timeline for a potential approval and highlights the significance of the underlying clinical data.
The submission is based on the Phase 2/3 IND.227/KEYNOTE-483 trial, which showed that KEYTRUDA plus chemotherapy improved overall survival compared to chemotherapy alone. If approved, this new treatment option could provide vital benefits to patients facing this aggressive form of cancer.
Read Announcement- Drug:
- KEYNOTE-483
- Announced Date:
- May 29, 2024
- Indication:
- For the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma.
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, Merck's anti-PD-1 therapy, in combination with chemotherapy, for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma.
AI Summary
Merck announced that the U.S. Food and Drug Administration (FDA) has accepted a new supplemental Biologics License Application (sBLA) for priority review. This sBLA seeks approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy, specifically for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. The application is based on promising results from the pivotal Phase 2/3 CCTG IND.227/KEYNOTE-483 trial, which demonstrated a statistically significant improvement in overall survival compared to chemotherapy alone. With a target action date set by the FDA under the Prescription Drug User Fee Act (PDUFA) on September 25, 2024, this potential approval could offer an important new treatment option for patients with this aggressive form of cancer, where the incidence of unresectable advanced disease significantly limits curative options.
Read Announcement
KEYNOTE-522 - FDA Regulatory Timeline and Events
KEYNOTE-522 is a drug developed by Merck & Co., Inc. for the following indication: in Patients With High-Risk Early-Stage Triple Negative Breast Cancer (TNBC).
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-522
- Announced Date:
- May 28, 2024
- Indication:
- in Patients With High-Risk Early-Stage Triple Negative Breast Cancer (TNBC)
Announcement
Merck announced that the Phase 3 KEYNOTE-522 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, met its overall survival (OS) endpoint, in combination with chemotherapy as pre-operative (neoadjuvant) treatment and then continuing as a single agent after surgery (adjuvant) for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC).
AI Summary
Merck announced that the Phase 3 KEYNOTE‑522 trial met its overall survival (OS) endpoint in patients with high‑risk early‑stage triple‑negative breast cancer (TNBC). In the study, patients received KEYTRUDA combined with chemotherapy before surgery (neoadjuvant treatment) and then continued with KEYTRUDA alone after surgery (adjuvant treatment). At a pre‑specified interim analysis by an independent Data Monitoring Committee, this regimen showed a statistically significant and clinically meaningful improvement in OS compared to pre‑operative chemotherapy alone.
The results build on earlier findings from the trial that showed a higher rate of pathological complete response and event‑free survival, highlighting the benefit of using an immunotherapy approach. The safety profile of KEYTRUDA was consistent with previous studies, with no new safety concerns emerging. These findings add valuable support for this therapy option in treating high‑risk early‑stage TNBC.
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KEYNOTE-671 - FDA Regulatory Timeline and 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.
Read Announcement- Drug:
- KEYNOTE-671
- Announced Date:
- May 15, 2024
- Indication:
- Evaluating neoadjuvant KEYTRUDA plus chemotherapy
Announcement
Merck announced First presentation of Phase 2b three-year follow-up data evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy, in combination with KEYTRUDA® (pembrolizumab) in patients with high-risk stage III/IV melanoma following complete resection
AI Summary
Merck has announced the first presentation of Phase 2b three-year follow-up data for its investigational therapy, mRNA-4157 (V940). This individualized neoantigen treatment is being studied in combination with KEYTRUDA® (pembrolizumab) for patients with high-risk stage III/IV melanoma who have undergone complete resection. The follow-up data provides early insights into the long-term potential of this treatment strategy in reducing the risk of melanoma recurrence.
The trial’s findings are significant as they demonstrate a personalized approach to cancer treatment by targeting specific tumor markers. By pairing mRNA-4157 with KEYTRUDA, researchers hope to offer improved outcomes and a more tailored therapy option for patients who face a high risk of relapse. These promising results could lead to further research and might play an essential role in shaping future melanoma treatment strategies.
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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:
- 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
- Estimated Event Date Range:
- June 23, 2025 - June 23, 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- Drug:
- KEYNOTE-689
- Announced Date:
- October 8, 2024
- Indication:
- In Patients With Resected, Locally Advanced Head and Neck Squamous Cell Carcinoma
Announcement
Merck announced that the Phase 3 KEYNOTE-689 trial evaluating KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as a perioperative treatment for patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell carcinoma (LA-HNSCC) met its primary endpoint of event-free survival (EFS).
AI Summary
Merck announced encouraging results from its Phase 3 KEYNOTE-689 trial for patients with stage III or IVA resected, locally advanced head and neck squamous cell carcinoma. The trial evaluated KEYTRUDA (pembrolizumab), an anti-PD-1 therapy, given before surgery (neoadjuvant) and combined with standard radiotherapy—with or without cisplatin—after surgery (adjuvant), followed by maintenance therapy. At a pre-specified interim analysis, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in event-free survival compared with radiotherapy alone.
These results also showed significant improvements in major pathological response, a key secondary endpoint. The safety profile was consistent with earlier studies, with no new safety concerns observed. Overall, these findings highlight the potential for KEYTRUDA to change how earlier stages of head and neck cancer are treated.
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KEYNOTE-811 - FDA Regulatory Timeline and Events
KEYNOTE-811 is a drug developed by Merck & Co., Inc. for the following indication: reatment of locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma.
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-811
- Announced Date:
- September 14, 2024
- Indication:
- reatment of locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma.
Announcement
Merck announced overall survival (OS) results from the final analysis of the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
AI Summary
Merck announced overall survival results from the final analysis of the Phase 3 KEYNOTE‑811 trial. This study evaluated KEYTRUDA® (pembrolizumab), Merck’s anti‑PD‑1 therapy, in combination with trastuzumab and fluoropyrimidine‑ and platinum‑containing chemotherapy for adults with locally advanced unresectable or metastatic HER2‑positive gastric or GEJ adenocarcinoma. After a median follow‑up of 50.2 months, patients who received the KEYTRUDA regimen experienced a 20% reduction in the risk of death compared to those on trastuzumab and chemotherapy alone. The median overall survival was 20.0 months with KEYTRUDA versus 16.8 months without it. In patients whose tumors expressed PD‑L1 (CPS ≥1), the benefit was similar, with median overall survival of 20.1 months compared to 15.7 months. These promising results were presented at the ESMO Congress 2024 and published in the New England Journal of Medicine.
Read Announcement- Drug:
- KEYNOTE-811
- Announced Date:
- May 1, 2024
- Indication:
- reatment of locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma.
Announcement
Merck announced that the Phase 3 KEYNOTE-811 trial evaluating KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy met its dual primary endpoint of overall survival (OS) for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
AI Summary
Merck announced that the Phase 3 KEYNOTE-811 trial met its dual primary endpoint of overall survival (OS) in patients with HER2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. In this trial, KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, was given in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy as a first-line treatment. The study showed a statistically significant and meaningful OS benefit when KEYTRUDA was added to the standard treatment compared to placebo, offering new hope for patients who typically face a poor prognosis with advanced gastric cancer. The trial’s safety profile remained consistent with previous studies, and the results will be shared at an upcoming medical meeting and with regulatory agencies worldwide.
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KEYNOTE-966 - FDA Regulatory Timeline and Events
KEYNOTE-966 is a drug developed by Merck & Co., Inc. for the following indication: anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin).
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-966
- Announced Date:
- May 15, 2024
- Indication:
- anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin)
Announcement
Merck announced that new data for four approved oncology medicines and four pipeline candidates in more than 25 types of cancer will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from May 31-June 4.
AI Summary
Merck announced that it will present new clinical data at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, scheduled from May 31 to June 4. This data covers four approved oncology medicines along with four pipeline candidates. The company’s research spans more than 25 different types of cancer, highlighting both established treatments and innovative therapeutic options in development.
The upcoming presentations demonstrate Merck’s ongoing commitment to advancing cancer treatment through robust clinical evidence. By sharing these findings at a major oncology event, Merck aims to provide healthcare professionals with valuable insights into the effectiveness and potential of these therapies. This initiative underscores the company’s efforts to improve patient outcomes and enhance the future management of cancer through research-driven progress.
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KEYNOTE-A18 - FDA Regulatory Timeline and 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:
- September 14, 2024
- Indication:
- For Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer
Announcement
Merck announced the first presentation of overall survival (OS) results from the pivotal Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047, investigating KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with concurrent chemoradiotherapy (CRT) for newly diagnosed patients with high-risk (stage IB2-IIB with lymph node-positive disease and stage III-IVA with and without lymph node-positive disease) locally advanced cervical cancer.
AI Summary
Merck recently presented the first overall survival (OS) results from the pivotal Phase 3 KEYNOTE-A18 trial, also known as ENGOT-cx11/GOG-3047. This trial is studying KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, when combined with concurrent chemoradiotherapy (CRT) in newly diagnosed high-risk locally advanced cervical cancer patients. The study focuses on patients with stage IB2-IIB cervical cancer with lymph node-positive disease and stage III-IVA patients, regardless of lymph node involvement. Early data show a promising trend in improved OS, supporting the potential benefit of integrating immunotherapy with standard CRT in this challenging disease setting. The ongoing follow-up will help further define the long-term survival benefits, potentially offering a new treatment option for patients with high-risk cervical cancer.
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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:
- 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.
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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:
- 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- Drug:
- KEYTRUDA®(pembrolizumab)
- Announced Date:
- December 16, 2024
- Indication:
- For the treatment of patients with locally advanced or metastatic urothelial carcinoma
Announcement
Merck announced KEYTRUDA, Merck's anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment after surgery for patients with resectable stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC).
AI Summary
Merck, known as MSD outside North America, announced that China's National Medical Products Administration (NMPA) has approved KEYTRUDA for treating resectable non-small cell lung cancer (NSCLC) at stage II, IIIA, or IIIB. This new approval allows KEYTRUDA to be used in combination with platinum-containing chemotherapy as a neoadjuvant treatment before surgery, then continued as a single-agent adjuvant therapy following surgery. It is the fourth indication for KEYTRUDA in NSCLC approved in China and the first targeting earlier-stage lung cancer. Clinical trial data have shown that this treatment can significantly improve overall survival for patients, offering a promising new option for a disease that remains the leading cause of cancer death in China. Merck’s commitment to advancing cancer research is further highlighted by this milestone, which addresses an unmet need in the treatment of earlier-stage NSCLC.
Read Announcement- Drug:
- KEYTRUDA®(pembrolizumab)
- Announced Date:
- September 20, 2024
- Indication:
- For the treatment of patients with locally advanced or metastatic urothelial carcinoma
Announcement
Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, for two indications in gynecologic cancers.
AI Summary
Merck recently announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending KEYTRUDA® (pembrolizumab) for two indications in gynecologic cancers. KEYTRUDA®, a leading anti-PD-1 therapy from Merck, is recognized for its role in bolstering the immune system to fight cancer. The CHMP’s decision reflects robust clinical evidence supporting its safety and effectiveness for women suffering from these specific forms of cancer, marking a promising step forward in expanding treatment options in gynecologic oncology. This recommendation highlights the growing trend of using immunotherapy to target and manage cancers in the female reproductive system. The positive opinions from the CHMP pave the way for further regulatory review and potential approval, which could soon offer new hope for improved patient outcomes and enhanced quality of life for those affected by gynecologic cancers.
Read Announcement- Drug:
- KEYTRUDA®(pembrolizumab)
- Announced Date:
- September 12, 2024
- Indication:
- For the treatment of patients with locally advanced or metastatic urothelial carcinoma
Announcement
Merck announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, as a monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options
AI Summary
Merck announced that Health Canada has approved KEYTRUDA® (pembrolizumab) as a standalone treatment for adult and pediatric patients with unresectable or metastatic MSI-H or dMMR solid tumors. These tumors are identified using a validated test and are typically found in patients whose cancers have progressed following prior treatments and who have no other satisfactory options.
The approval is based on data from the KEYNOTE-158, KEYNOTE-164, and KEYNOTE-051 trials, which together studied over 500 patients across more than 30 types of cancer. KEYTRUDA works by blocking the PD-1 protein, enhancing the body’s immune response against tumor cells. This regulatory update represents a significant advancement in meeting the unmet medical needs of patients with difficult-to-treat cancers in Canada.
Read Announcement- Drug:
- KEYTRUDA®(pembrolizumab)
- Announced Date:
- September 4, 2024
- Indication:
- For the treatment of patients with locally advanced or metastatic urothelial carcinoma
Announcement
Merck announced that new data for four approved medicines and six pipeline candidates in more than 20 types of cancer will be presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, from Sept. 13-17. Study findings from the Phase 3 KEYNOTE-522 trial (#LBA4) in high-risk early-stage triple-negative breast cancer (TNBC), the Phase 3 KEYNOTE-A18 trial (#709O) in high-risk locally advanced cervical cancer and the Phase 3 LEAP-012 trial (#LBA3) in unresectable, non-metastatic hepatocellular carcinoma, in collaboration with Eisai, have been selected for the ESMO Presidential Symposium Sessions.
AI Summary
Merck announced that new clinical data for four approved medicines and six pipeline candidates in more than 20 types of cancer will be showcased at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain, from September 13-17. Key studies selected for the Presidential Symposium sessions include Phase 3 KEYNOTE-522 for high‐risk early‐stage triple‐negative breast cancer, Phase 3 KEYNOTE-A18 for high-risk locally advanced cervical cancer, and Phase 3 LEAP-012 for patients with unresectable, non-metastatic hepatocellular carcinoma—in collaboration with Eisai. This data presentation highlights Merck’s comprehensive oncology portfolio and ongoing commitment to advancing cancer research across multiple tumor types, aiming to improve patient outcomes with both approved treatments and promising investigational therapies.
Read Announcement- Drug:
- KEYTRUDA®(pembrolizumab)
- Announced Date:
- September 3, 2024
- Indication:
- For the treatment of patients with locally advanced or metastatic urothelial carcinoma
Announcement
Merck announced that the European Commission (EC) has approved KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults.
AI Summary
Merck announced that the European Commission has approved KEYTRUDA® (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults. This new approval marks a significant development in the treatment options for patients with advanced bladder cancer. The combination is now recommended as the preferred first-line treatment by both the European Society for Medical Oncology and the European Association of Urology, regardless of a patient’s eligibility for platinum-based chemotherapy. Positive results from the Phase 3 KEYNOTE-A39 trial, which showed notable improvements in overall and progression-free survival compared to standard platinum-based chemotherapy, supported this decision. The new regimen will be available across all EU member states and selected additional regions, offering hope for better outcomes and extended survival for patients with this aggressive cancer type.
Read Announcement- Drug:
- KEYTRUDA®(pembrolizumab)
- Announced Date:
- July 26, 2024
- Indication:
- For the treatment of patients with locally advanced or metastatic urothelial carcinoma
Announcement
Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck's anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
AI Summary
Merck announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of KEYTRUDA in combination with Padcev (enfortumab vedotin-ejfv) for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma in Europe. This recommendation is based on interim data from the Phase 3 KEYNOTE-A39 trial, which demonstrated significant improvements in overall survival and progression-free survival compared to traditional platinum-based chemotherapy. The trial showed a 53% reduction in the risk of death and a 55% decrease in the risk of disease progression, offering hope for a new treatment option for advanced bladder cancer patients. The positive CHMP opinion marks a key step forward toward establishing a new standard of care, and the final decision now awaits review by the European Commission, with an announcement expected later in 2024.
Read Announcement- Drug:
- KEYTRUDA®(pembrolizumab)
- Announced Date:
- May 9, 2024
- Indication:
- For the treatment of patients with locally advanced or metastatic urothelial carcinoma
Announcement
Merck announced that the Phase 3 KEYNOTE-B21 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with chemotherapy as adjuvant treatment, with or without radiotherapy, did not meet its primary endpoint of disease-free survival (DFS) for the treatment of patients with newly diagnosed, high-risk endometrial cancer after surgery with curative intent.
AI Summary
Merck announced that its Phase 3 KEYNOTE-B21 trial did not meet the primary endpoint of disease-free survival (DFS) for patients with newly diagnosed, high-risk endometrial cancer. The trial was designed to assess KEYTRUDA—Merck's anti-PD-1 therapy—when combined with chemotherapy as an adjuvant treatment, with or without radiotherapy, after surgery with curative intent. This trial aimed to determine if adding KEYTRUDA to the standard treatment regimen could improve DFS in high-risk patients. However, the results did not show a significant benefit in terms of extending the time patients remained free from cancer recurrence. These findings suggest that the combination of KEYTRUDA with chemotherapy (and possible radiotherapy) may not offer the expected improvements in outcomes for this patient group, prompting further research into more effective treatment options for high-risk endometrial cancer.
Read Announcement- Drug:
- KEYTRUDA®(pembrolizumab)
- Announced Date:
- April 19, 2024
- Indication:
- For the treatment of patients with locally advanced or metastatic urothelial carcinoma
Announcement
Merck announced that Health Canada has granted approval of KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing-chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
AI Summary
Merck announced that Health Canada has approved KEYTRUDA® (pembrolizumab) when used with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. The decision was based on the Phase 3 KEYNOTE-859 trial, which showed significant improvements in overall survival, progression-free survival, and objective response rate compared to chemotherapy alone. This new approval marks an important milestone in expanding treatment options for a patient population that often faces late detection and poor outcomes. According to Merck, the expanded indication of KEYTRUDA® represents their commitment to offer better treatment options and improve health outcomes for patients battling advanced gastric cancer.
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KeyVibe-008 - FDA Regulatory Timeline and Events
KeyVibe-008 is a drug developed by Merck & Co., Inc. for the following indication: In Patients With Extensive-Stage Small Cell Lung 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:
- KeyVibe-008
- Announced Date:
- August 8, 2024
- Indication:
- In Patients With Extensive-Stage Small Cell Lung Cancer
Announcement
Merck announced the discontinuation of the Phase 3 KeyVibe-008 trial based on the recommendation of an independent Data Monitoring Committee (DMC).
AI Summary
Merck has announced that it is discontinuing the Phase 3 KeyVibe-008 trial following a recommendation from an independent Data Monitoring Committee. The trial was evaluating a fixed-dose combination of vibostolimab, an investigational anti-TIGIT antibody, and pembrolizumab in combination with chemotherapy as a first-line treatment for patients with extensive-stage small cell lung cancer. An analysis revealed that the study’s primary endpoint of overall survival met pre-specified futility criteria. Additionally, the combination arm experienced a higher rate of adverse events compared to the control group using atezolizumab with chemotherapy.
Following the decision, Merck has informed investigators that patients should stop the treatment with the fixed-dose combination and be offered atezolizumab instead. The company plans to share the study results with the scientific community as it continues its efforts to explore novel treatment options in lung cancer.
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KeyVibe-010 - FDA Regulatory Timeline and Events
KeyVibe-010 is a drug developed by Merck & Co., Inc. for the following indication: Treatment for Patients With Resected High-Risk Melanoma.
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:
- KeyVibe-010
- Announced Date:
- May 13, 2024
- Indication:
- Treatment for Patients With Resected High-Risk Melanoma
Announcement
Merck announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial.
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LEAP-015 - FDA Regulatory Timeline and Events
LEAP-015 is a drug developed by Merck & Co., Inc. for the following indication: For Gastroesophageal Adenocarcinoma.
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-015
- Announced Date:
- January 24, 2025
- Indication:
- For Gastroesophageal Adenocarcinoma
Announcement
Merck announced results from the Phase 3 LEAP-015 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 chemotherapy (KEYTRUDA plus LENVIMA-based regimen), for the first-line treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastroesophageal adenocarcinoma.
AI Summary
Merck and Eisai released results from the Phase 3 LEAP-015 trial testing the combination of KEYTRUDA® (pembrolizumab) plus LENVIMA® (lenvatinib) with chemotherapy for first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastroesophageal adenocarcinoma. At an interim analysis, the KEYTRUDA plus LENVIMA regimen showed a statistically significant improvement in progression-free survival and a better objective response rate compared to standard chemotherapy. However, the final results did not meet the trial’s primary overall survival endpoint. The safety profile of the combination was consistent with previous studies evaluating these treatments. The companies highlighted that the findings contribute to the understanding of this challenging cancer and will guide future research, with further detailed results to be presented at an upcoming medical meeting.
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LINE-007 - FDA Regulatory Timeline and Events
LINE-007 is a drug developed by Merck & Co., Inc. for the following indication: For 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-007
- Announced Date:
- December 8, 2024
- Indication:
- For Diffuse Large B-Cell Lymphoma
Announcement
Merck announced the first presentation of data from the Phase 2 waveLINE-007 trial evaluating zilovertamab vedotin, Merck's investigational antibody drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1), in combination with cyclophosphamide, doxorubicin and prednisone plus rituximab (R-CHP) for the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
AI Summary
Merck recently presented the first data from its Phase 2 waveLINE-007 trial evaluating the investigational antibody-drug conjugate, zilovertamab vedotin, in combination with R-CHP (cyclophosphamide, doxorubicin, prednisone plus rituximab) for patients with previously untreated diffuse large B-cell lymphoma (DLBCL). The trial focused on doses of zilovertamab vedotin targeting ROR1, and the 1.75 mg/kg dose showed remarkable results. In this cohort of 15 patients, 100% achieved a complete response, leading the researchers to establish 1.75 mg/kg as the recommended dose for the Phase 3 trial. These promising early results suggest that combining zilovertamab vedotin with the current standard therapy could offer a new first-line treatment option for DLBCL, addressing an unmet need in treatment as many patients experience relapse or refractory disease with standard care.
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LINE-010 - FDA Regulatory Timeline and 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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LYNPARZA (Olaparib) - FDA Regulatory Timeline and Events
LYNPARZA (Olaparib) is a drug developed by Merck & Co., Inc. for the following indication: BRCA-Mutated Metastatic Castration-Resistant Prostate 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:
- LYNPARZA (Olaparib)
- Announced Date:
- August 14, 2024
- Indication:
- BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
Announcement
AstraZeneca announced that Lynparza (olaparib) have been approved in the European Union (EU) as treatment for certain patients with primary advanced or recurrent endometrial cancer.
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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:
- 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.
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MK-1654 - FDA Regulatory Timeline and Events
MK-1654 is a drug developed by Merck & Co., Inc. for the following indication: An Investigational Respiratory Syncytial Virus Preventative Monoclonal Antibody for Infants.
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-1654
- Announced Date:
- December 17, 2024
- Indication:
- An Investigational Respiratory Syncytial Virus Preventative Monoclonal Antibody for Infants
Announcement
Merck announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), the company's investigational prophylactic long-acting monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season.
AI Summary
Merck announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for clesrovimab (MK-1654). This investigational, long-acting monoclonal antibody is designed as a single-dose immunization to protect infants during their first RSV season regardless of their weight. The FDA set a target action date for June 10, 2025, with Merck aiming to have clesrovimab available in time for the 2025-26 RSV season.
Merck’s announcement highlights promising results from pivotal clinical trials supporting the drug’s efficacy in preventing RSV disease. This step is viewed as a significant milestone, as RSV continues to pose serious health risks to infants and challenges to families and the healthcare system. If approved, clesrovimab could help address unmet needs by offering a new preventive option for one of the leading causes of infant hospitalizations.
Read Announcement- Drug:
- MK-1654
- Announced Date:
- July 23, 2024
- Indication:
- An Investigational Respiratory Syncytial Virus Preventative Monoclonal Antibody for Infants
Announcement
Merck announced positive topline results from its Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab (MK-1654), the company's investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease.
AI Summary
Merck (known as MSD outside the United States and Canada) announced positive topline results from its Phase 2b/3 trial MK-1654-004 evaluating clesrovimab, an investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease. The study met all primary safety and efficacy endpoints, including a significant reduction in medically attended lower respiratory infections (MALRI) caused by RSV through Day 150. Designed as a single, fixed-dose administration, clesrovimab could offer rapid and durable protection during an infant’s first RSV season. These promising results highlight clesrovimab’s potential in helping to lower RSV-related hospitalizations among healthy and high-risk infants alike. Detailed findings from the trial will be presented at an upcoming scientific congress as Merck prepares to file the data with global regulatory authorities.
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MK-3475A-D77 - FDA Regulatory Timeline and 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.
Read Announcement- Drug:
- MK-3475A-D77
- Announced Date:
- November 19, 2024
- Indication:
- For the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC).
Announcement
Merck announced positive topline results from the pivotal Phase 3 MK-3475A-D77 trial. The trial is evaluating the noninferiority of subcutaneous administration of pembrolizumab, Merck's anti-PD-1 therapy, available for intravenous use as KEYTRUDA®, together with berahyaluronidase alfa, a hyaluronidase variant developed and manufactured by Alteogen Inc.
AI Summary
Merck announced strong topline results from its pivotal Phase 3 MK-3475A-D77 trial. The study evaluated whether subcutaneously administered pembrolizumab, combined with berahyaluronidase alfa (a hyaluronidase variant from Alteogen Inc.), is as effective as the traditional intravenous KEYTRUDA® when given with chemotherapy for metastatic non‑small cell lung cancer. The trial met both primary pharmacokinetic endpoints, showing that the exposure and trough concentrations of pembrolizumab were noninferior in the subcutaneous formulation compared to the intravenous method.
These positive results could improve the patient experience by offering a faster, less invasive administration method while maintaining treatment effectiveness. Merck plans to discuss these findings with regulatory authorities worldwide as part of their continued efforts to expand treatment options in cancer care.
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MK-7240 - FDA Regulatory Timeline and 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:
- September 26, 2024
- Indication:
- In Inflammatory Bowel Disease
Announcement
Merck announced that new data highlighting the long-term efficacy and safety of tulisokibart (MK-7240), an investigational humanized monoclonal antibody directed to a novel target, tumor necrosis factor (TNF)-like cytokine 1A (TL1A), in ulcerative colitis (UC) and Crohn's disease (CD) will be presented at the United European Gastroenterology (UEG) Week 2024 Congress in Vienna, Austria.
AI Summary
Merck has announced new data on the long-term efficacy and safety of tulisokibart (MK-7240), an investigational humanized monoclonal antibody designed to target TL1A, a protein linked to inflammatory bowel disease. These findings, drawn from the open-label extensions of the Phase 2 ARTEMIS-UC and APOLLO-CD studies, will be presented in two oral sessions at the United European Gastroenterology Week 2024 Congress in Vienna, Austria. The data show that patients with ulcerative colitis and Crohn’s disease who responded during the 12-week induction phase maintained their treatment benefits through week 50, with a safety profile consistent with earlier research. Merck’s new results support the potential of tulisokibart as a promising treatment option for patients who have not achieved long-term remission with current therapies.
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MK-8527 - FDA Regulatory Timeline and 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 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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Molnupiravir (MK-4482) - FDA Regulatory Timeline and Events
Molnupiravir (MK-4482) is a drug developed by Merck & Co., Inc. for the following indication: Covid-19.
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:
- Molnupiravir (MK-4482)
- Announced Date:
- December 5, 2024
- Indication:
- Covid-19
Announcement
Merck announced the initiation of the Phase 3 MOVe-NOW clinical trial to evaluate LAGEVRIOTM (molnupiravir), an investigational oral antiviral COVID-19 medicine, for the treatment of adults with COVID-19 at high risk for disease progression.
AI Summary
Merck has launched the Phase 3 MOVe-NOW clinical trial to study LAGEVRIO (molnupiravir), an investigational oral antiviral medicine for COVID-19. This global, double-blind, placebo-controlled trial will evaluate the drug in non-hospitalized adults with COVID-19 who are at high risk for disease progression. Participants must have tested positive for COVID-19 and experienced symptoms for four days or less, and the trial will focus on those who cannot take nirmatrelvir/ritonavir due to drug interactions, allergies, or other concerns.
The study will use a new formulation of LAGEVRIO that consists of two 400-mg tablets per dose, simplifying the dosing schedule compared to the current capsules. Merck believes that further data on LAGEVRIO’s effectiveness in preventing severe COVID-19 outcomes in high-risk patients will be valuable, especially as the pandemic continues to evolve.
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NRG-GY018 - FDA Regulatory Timeline and 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 approved 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.
Read Announcement- Drug:
- NRG-GY018
- Announced Date:
- June 17, 2024
- Indication:
- Evaluating KEYTRUDA in combination with standard of care chemotherapy (paclitaxel and carboplatin)
Announcement
Merck announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, 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 the U.S. FDA has approved KEYTRUDA, an anti-PD-1 therapy, in combination with carboplatin and paclitaxel, followed by KEYTRUDA alone, for treating adult patients with primary advanced or recurrent endometrial carcinoma. This is the first anti-PD-1 therapy approved with chemotherapy for this indication, regardless of the tumor’s mismatch repair status.
The approval is based on positive results from a Phase 3 study, which demonstrated a statistically significant reduction in the risk of disease progression or death for both mismatch repair proficient and deficient patients. This new treatment option enhances frontline care for advanced endometrial cancer and adds to KEYTRUDA’s portfolio of approved indications in the U.S. as Merck continues to advance innovative cancer therapies.
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NUMELVI™ - FDA Regulatory Timeline and 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:
- 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.
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Restoret™ - FDA Regulatory Timeline and Events
Restoret™ is a drug developed by Merck & Co., Inc. for the following indication: For the Treatment of Diabetic Macular Edema.
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:
- Restoret™
- Announced Date:
- September 4, 2024
- Indication:
- For the Treatment of Diabetic Macular Edema
Announcement
Merck announced the initiation of the Phase 2b/3 BRUNELLO trial evaluating Restoret™ (MK-3000, formerly EYE103) for the treatment of diabetic macular edema (DME).
AI Summary
Merck announced the start of a Phase 2b/3 BRUNELLO trial to evaluate Restoret™ (MK-3000, formerly known as EYE103) for the treatment of diabetic macular edema (DME). DME is a condition where fluid builds up in the retina due to diabetes, potentially leading to vision loss. This new trial aims to assess both the safety and effectiveness of Restoret™, representing Merck’s latest effort to address this significant unmet need in eye care. If successful, the treatment could offer a novel therapeutic option for patients suffering from DME, helping to prevent progression of vision impairment and improve overall quality of life. The initiation of this trial highlights Merck’s continued commitment to advancing innovative therapies in the field of ophthalmology.
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sac-TMT - FDA Regulatory Timeline and Events
sac-TMT is a drug developed by Merck & Co., Inc. for the following indication: For the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer With EGFR Mutations.
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:
- sac-TMT
- Announced Date:
- December 3, 2024
- Indication:
- For the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer With EGFR Mutations
Announcement
Merck announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to sacituzumab tirumotecan (sac-TMT) for the treatment of patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations (exon 19 deletion [19del] or exon 21 L858R) whose disease progressed on or after tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.
AI Summary
Merck announced that the U.S. FDA granted Breakthrough Therapy designation for sacituzumab tirumotecan (sac-TMT) to treat patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have EGFR mutations (either exon 19 deletion or exon 21 L858R) and whose cancer has progressed after treatment with tyrosine kinase inhibitors and platinum-based chemotherapy. This designation acknowledges promising early data from clinical studies and signals the FDA’s support to speed up the development and review process.
By focusing on this patient group with serious unmet medical needs, Merck hopes to improve treatment outcomes. The expedited program means that sac-TMT may receive more intensive guidance from the FDA during its clinical trials, potentially leading to a faster path to market if future studies continue to show positive results.
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Sotatercept - FDA Regulatory Timeline and 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:
- August 26, 2024
- Indication:
- Pulmonary Arterial Hypertension (PAH)
Announcement
Merck announced that the European Commission (EC) has approved WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with World Health Organization (WHO) Functional Class (FC) II to III, to improve exercise capacity.
AI Summary
Merck announced that the European Commission (EC) has approved WINREVAIR™ (sotatercept) for use in adult patients with pulmonary arterial hypertension (PAH) who are in World Health Organization Functional Class II to III. This new treatment, used alongside other PAH therapies, is designed to improve patients’ exercise capacity. WINREVAIR is the first activin signaling inhibitor approved in Europe, marking a major step forward for PAH treatment. The approval was based on promising safety and efficacy data from the Phase 3 STELLAR trial, which showed that adding WINREVAIR to standard therapies resulted in significant improvements in exercise performance and reduced the risk of death or clinical worsening events.
This positive decision by the EC paves the way for more patients in Europe to access this innovative treatment, aiming to offer improved outcomes in managing the symptoms of PAH.
Read Announcement- Drug:
- Sotatercept
- Announced Date:
- June 28, 2024
- Indication:
- Pulmonary Arterial Hypertension (PAH)
Announcement
Merck announced that that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of WINREVAIR™ (sotatercept), in combination with other pulmonary arterial hypertension (PAH) therapies, for the treatment of PAH in adult patients with World Health Organization (WHO) Functional Class (FC) II to III, to improve exercise capacity.
AI Summary
Merck recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of WINREVAIR™ (sotatercept). If approved by the European Commission, WINREVAIR will be used along with other pulmonary arterial hypertension (PAH) therapies to treat adult patients with WHO Functional Class II and III. This new treatment is the first activin signaling inhibitor therapy for PAH in Europe, filling a critical need for patients suffering from this rare and progressive disease.
The recommendation was based on the Phase 3 STELLAR trial, which showed that WINREVAIR provided a statistically significant improvement in exercise capacity, as measured by the 6-minute walk distance, along with other key clinical benefits. The European Commission is expected to review the marketing authorization in the third quarter of 2024.
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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:
- July 2, 2025
- Estimated Event Date Range:
- October 25, 2025 - October 25, 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- Drug:
- sotatercept-csrk
- Announced Date:
- November 25, 2024
- Indication:
- In adults with pulmonary arterial hypertension
Announcement
Merck announced positive topline results from the Phase 3 ZENITH study evaluating WINREVAIR (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH, WHO* Group 1) functional class (FC) III or IV at high risk of mortality.
AI Summary
Merck recently announced positive topline results from the Phase 3 ZENITH study evaluating WINREVAIR (sotatercept-csrk) in adults with pulmonary arterial hypertension (PAH) in functional class III or IV who are at high risk of mortality. The study met its primary endpoint by showing a statistically significant and clinically meaningful reduction in the time to the first event of morbidity or mortality, which includes all-cause death, lung transplantation, or PAH-related hospitalizations of at least 24 hours.
Due to these impressive results, an independent data monitoring committee recommended ending the trial early. All participants in the study will now be given the opportunity to receive WINREVAIR through an open-label extension study. These findings add to the growing evidence that WINREVAIR could be a practice-changing treatment for patients facing severe PAH.
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V116 (21-valent pneumococcal conjugate vaccine) - FDA Regulatory Timeline and Events
V116 (21-valent pneumococcal conjugate vaccine) is a drug developed by Merck & Co., Inc. for the following indication: Pneumococcal Disease and Pneumococcal Pneumonia in Adults.
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:
- V116 (21-valent pneumococcal conjugate vaccine)
- Announced Date:
- April 29, 2024
- Estimated Event Date Range:
- June 17, 2024 - June 17, 2024
- Target Action Date:
- June 17, 2024
- Indication:
- Pneumococcal Disease and Pneumococcal Pneumonia in Adults
Announcement
Merck announced that The FDA granted V116 priority review with a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024.
AI Summary
Merck announced that its investigational 21-valent pneumococcal conjugate vaccine, V116, has been granted priority review by the Food and Drug Administration (FDA). The FDA’s decision assigns a Prescription Drug User Fee Act (PDUFA) target action date of June 17, 2024. This designation highlights the potential of V116 to address significant gaps in current pneumococcal disease prevention for adults, particularly those aged 50 and older.
V116 is designed to protect against serotypes that contribute to the majority of invasive pneumococcal disease cases among older adults. The recent Phase 3 STRIDE-10 trial showed that V116 elicited robust immune responses, with similar or improved results compared to the existing 23-valent vaccine for many serotypes. The FDA’s priority review is a key step in evaluating V116’s potential to become an important new option for preventing pneumococcal infections in the adult population.
Read Announcement- Drug:
- V116 (21-valent pneumococcal conjugate vaccine)
- Announced Date:
- April 29, 2024
- Indication:
- Pneumococcal Disease and Pneumococcal Pneumonia in Adults
Announcement
Merck announced results from STRIDE-10, a Phase 3 trial evaluating V116, the company's investigational, adult-specific 21-valent pneumococcal conjugate vaccine, at the 34th European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) in Barcelona, Spain
AI Summary
Merck shared encouraging results from the STRIDE-10 Phase 3 trial during an oral presentation at the 34th ESCMID Global in Barcelona. The study focused on V116, Merck’s investigational, adult-specific 21-valent pneumococcal conjugate vaccine, and evaluated its ability to stimulate the immune system in adults aged 50 and older who had not previously received any pneumococcal vaccine. V116 not only met the noninferiority criteria for the 12 serotypes common with the existing 23-valent vaccine but also showed superior immune responses for the nine unique serotypes included only in V116. Additionally, the vaccine demonstrated a safety profile comparable to that of the 23-valent vaccine. These promising results suggest that V116 could offer improved protection against the serotypes most responsible for invasive pneumococcal disease in adults, potentially filling critical gaps in current pneumococcal disease prevention.
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V181 - FDA Regulatory Timeline and 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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V940-001 - FDA Regulatory Timeline and Events
V940-001 is a drug developed by Merck & Co., Inc. for the following indication: for Adjuvant Treatment of Patients with Resected High-Risk (Stage IIB-IV) Melanoma.
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:
- V940-001
- Announced Date:
- May 15, 2024
- Indication:
- for Adjuvant Treatment of Patients with Resected High-Risk (Stage IIB-IV) Melanoma
Announcement
Merck announced First presentation of Phase 2b three-year follow-up data evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy, in combination with KEYTRUDA® (pembrolizumab) in patients with high-risk stage III/IV melanoma following complete resection
AI Summary
Merck recently shared promising results from its Phase 2b clinical trial involving mRNA-4157 (V940), an investigational individualized neoantigen therapy. In this study, the therapy was combined with KEYTRUDA® (pembrolizumab) and given to patients with high-risk stage III/IV melanoma who had completed tumor resection. The three-year follow-up data marks the first detailed clinical presentation of this regimen. The study aims to improve immune system responses by targeting unique tumor mutations, which could help prevent cancer recurrence and extend patient survival. Merck’s findings show encouraging longer-term outcomes and support further investigation into this innovative treatment strategy. By focusing on a combination of immunotherapy treatments, the research team hopes to offer a new option for patients facing advanced melanoma, paving the way for additional research and potentially improved quality of life for these individuals.
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waveLINE-003 - FDA Regulatory Timeline and 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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