This section highlights FDA-related milestones and regulatory updates for drugs developed by Pfizer (PFE).
Over the past two years, Pfizer has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ABRYSVO, ADCETRIS, BRAFTOVI, BRAFTOVI®, CABOTEGRAVIR, CIFFREO, and COMIRNATY®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ABRYSVO - FDA Regulatory Timeline and Events
ABRYSVO is a drug developed by Pfizer for the following indication: Vaccine indicated for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in people 60 years of age and older.
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:
- ABRYSVO
- Announced Date:
- April 16, 2025
- Indication:
- Vaccine indicated for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in people 60 years of age and older.
Announcement
Pfizer Inc. that the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of respiratory syncytial virus (RSV) vaccines approved for adults 50-59 years of age at increased risk of RSV-associated lower respiratory tract disease (LRTD).
AI Summary
The CDC’s ACIP has voted to expand the recommendation for using RSV vaccines to include adults aged 50-59 who are at increased risk of severe lower respiratory tract disease. Pfizer highlighted that this expansion now targets a broader group compared to previous guidelines that were limited to older adults and those with high-risk conditions. The decision means that high-risk adults in the 50-59 age group, such as individuals with obesity, cardiovascular disease, diabetes, COPD, asthma, or other chronic conditions, could receive a single dose of the vaccine to help prevent serious RSV illness.
This update is significant because it lowers the age threshold for high-risk patients, aiming to reduce the 15,000-20,000 annual RSV-associated hospitalizations observed in this age group. The recommendation is pending final approval from the CDC director and the Department of Health and Human Services.
Read Announcement- Drug:
- ABRYSVO
- Announced Date:
- April 1, 2025
- Indication:
- Vaccine indicated for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in people 60 years of age and older.
Announcement
Pfizer Inc announced that the European Commission (EC) has issued a decision amending the marketing authorization for ABRYSVO®, the company's bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to extend the indication to include prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age
AI Summary
Pfizer Inc announced that the European Commission has updated the marketing authorization for its ABRYSVO® vaccine. The amendment now allows the vaccine to be used for preventing lower respiratory tract disease (LRTD) caused by RSV in individuals aged 18 through 59 years, in addition to those 60 and older. This decision marks a significant expansion of the vaccine’s approved use in the European Union, making it the broadest RSV vaccine indication available. The extended authorization means the vaccine can now actively immunize adults from 18 years of age, while also offering passive protection for infants when pregnant individuals are immunized during the specified gestation period. Pfizer highlighted that these changes are based on positive outcomes from clinical studies, and the decision is expected to contribute to reducing RSV-related hospital admissions and lowering the public health burden in future seasons.
Read Announcement- Drug:
- ABRYSVO
- Announced Date:
- August 12, 2024
- Indication:
- Vaccine indicated for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in people 60 years of age and older.
Announcement
Pfizer Inc announced positive top-line safety and immunogenicity results from substudy B of the ongoing pivotal Phase 3 clinical trial (NCT05842967) MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness),evaluating two doses of ABRYSVO vaccine in immunocompromised adults aged 18 and older at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD).
AI Summary
Pfizer recently announced positive top-line safety and immunogenicity results from substudy B of its ongoing Phase 3 MONeT trial (NCT05842967). This study focused on immunocompromised adults aged 18 and older who are at increased risk for severe RSV-associated lower respiratory tract disease. Participants, including cancer patients, hemodialysis recipients, those on immunomodulator therapy for autoimmune disorders, and solid organ transplant recipients, received two doses of the ABRYSVO vaccine one month apart.
Notably, a single 120 µg dose of ABRYSVO generated a strong neutralizing response against both RSV-A and RSV-B across various age groups and cohorts. The vaccine was well-tolerated and demonstrated a consistent safety profile with previous studies. These encouraging results provide important evidence of ABRYSVO’s potential to protect vulnerable, immunocompromised adults from severe RSV complications.
Read Announcement- Drug:
- ABRYSVO
- Announced Date:
- April 9, 2024
- Indication:
- Vaccine indicated for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in people 60 years of age and older.
Announcement
Pfizer Inc announced positive top-line immunogenicity and safety data from the ongoing pivotal Phase 3 clinical trial (NCT05842967) MONeT (RSV IMmunizatiON Study for AdulTs at Higher Risk of Severe Illness),evaluating a single dose of ABRYSVO versus placebo in adults 18 to 59 years of age at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD).
AI Summary
Pfizer announced positive top-line data from the pivotal Phase 3 MONeT trial, which evaluated a single dose of ABRYSVO versus a placebo in adults aged 18 to 59 at risk of severe RSV-associated lower respiratory tract disease. The study met its primary immunogenicity and safety endpoints, showing that the immune responses for both RSV-A and RSV-B were not inferior to those seen in older adults from previous studies. Participants experienced at least a four-fold increase in neutralizing antibody levels one month after vaccination, and the vaccine was well-tolerated overall.
Based on these encouraging results, Pfizer plans to submit the data to regulatory agencies to seek approval for ABRYSVO in adults 18 to 59 years old. The company hopes to address the unmet need for effective RSV protection in this age group, especially for individuals with chronic conditions such as asthma, diabetes, or chronic obstructive pulmonary disease.
Read Announcement
ADCETRIS - FDA Regulatory Timeline and Events
ADCETRIS is a drug developed by Pfizer for the following indication: Prescription medicine directed against the CD30 protein.
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:
- ADCETRIS
- Announced Date:
- February 12, 2025
- Indication:
- Prescription medicine directed against the CD30 protein
Announcement
Pfizer Inc announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for ADCETRIS® (brentuximab vedotin) in combination with lenalidomide and a rituximab product for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy.
AI Summary
Pfizer Inc. announced that the FDA has approved a supplemental Biologics License Application (sBLA) for ADCETRIS® (brentuximab vedotin) combined with lenalidomide and a rituximab product. This new approval is for treating adult patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL from indolent lymphoma, or high-grade B-cell lymphoma. The treatment is recommended for patients who have received at least two prior lines of systemic therapy and who are not eligible for autologous hematopoietic stem cell transplantation or CAR T-cell therapy. The decision was based on positive results from the Phase 3 ECHELON-3 trial, which showed a 37% reduction in the risk of death compared to a control group. This approval provides physicians with a new therapeutic option beyond traditional chemotherapy and CAR-T therapies.
Read Announcement- Drug:
- ADCETRIS
- Announced Date:
- June 1, 2024
- Indication:
- Prescription medicine directed against the CD30 protein
Announcement
Takeda and Pfizer announced that the German Hodgkin Study Group (GHSG) will present positive results from the Phase 3 HD21 trial evaluating ADCETRIS® (brentuximab vedotin) in combination with chemotherapy as a late-breaking oral presentation at the 60th American Society of Clinical Oncology (ASCO) Annual Meeting (LBA7000) and at the 29th European Hematology Association (EHA) Annual Meeting (S225).
AI Summary
Takeda and Pfizer recently announced positive Phase 3 HD21 trial results for ADCETRIS® (brentuximab vedotin) in combination with chemotherapy, set to be shared by the German Hodgkin Study Group (GHSG). These results will be featured as a late-breaking oral presentation at the 60th American Society of Clinical Oncology (ASCO) Annual Meeting (LBA7000), as well as at the 29th European Hematology Association (EHA) Annual Meeting (S225). The data suggest that the ADCETRIS regimen offers significant benefits for patients with advanced classical Hodgkin lymphoma, supporting its potential to improve overall survival outcomes. The upcoming presentations aim to provide additional insights into how the combination treatment is effective and further solidify ADCETRIS’s role as a promising option in the evolving treatment landscape for this lymphoma subtype.
Read Announcement
BRAFTOVI - FDA Regulatory Timeline and Events
BRAFTOVI is a drug developed by Pfizer for the following indication: In Patients with BRAF V600E-Mutant 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:
- BRAFTOVI
- Announced Date:
- May 30, 2025
- Indication:
- In Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer
Announcement
Pfizer Inc. announced statistically significant and clinically meaningful survival results from the Phase 3 BREAKWATER trial evaluating BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation.
AI Summary
Pfizer announced breakthrough survival results from the Phase 3 BREAKWATER trial for patients with metastatic colorectal cancer featuring a BRAF V600E mutation. In this study, the combination of BRAFTOVI® (encorafenib) with cetuximab (ERBITUX®) and mFOLFOX6 significantly improved outcomes. The treatment reduced the risk of death by 51% compared to standard chemotherapy, with a median overall survival of 30.3 months versus 15.1 months in the control group. Additionally, the regimen lowered the risk of disease progression or death by 47%. These findings represent an important advancement by offering the first targeted treatment option for treatment-naïve patients with this aggressive form of cancer. The results are considered both statistically significant and clinically meaningful, and they will be presented at the 2025 ASCO Annual Meeting as well as published in the New England Journal of Medicine.
Read Announcement- Drug:
- BRAFTOVI
- Announced Date:
- February 3, 2025
- Indication:
- In Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer
Announcement
Pfizer Inc. announced positive topline results from the progression-free survival (PFS) analysis of the Phase 3 BREAKWATER study of BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) harboring a BRAF V600E mutation.
AI Summary
Pfizer Inc. announced positive topline results from the progression-free survival (PFS) analysis of the Phase 3 BREAKWATER study. The study evaluated BRAFTOVI® (encorafenib) in combination with cetuximab (ERBITUX®) and mFOLFOX6 for patients with metastatic colorectal cancer that carries a BRAF V600E mutation. The trial met its primary endpoint by showing a statistically significant and clinically meaningful improvement in PFS as determined by blinded independent central review. In addition, the combination demonstrated a significant boost in overall survival, offering new hope for a patient population that has had very limited treatment options. Pfizer plans to share these promising results with the U.S. FDA, aiming to support the potential conversion of this treatment’s accelerated approval to full approval, which could make this new targeted therapy a new standard of care for these patients.
Read Announcement- Drug:
- BRAFTOVI
- Announced Date:
- January 25, 2025
- Indication:
- In Patients with BRAF V600E-Mutant Metastatic Colorectal Cancer
Announcement
Pfizer Inc announced positive results from the Phase 3 BREAKWATER trial evaluating BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX®) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) in patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation.
AI Summary
Pfizer announced encouraging findings from its Phase 3 BREAKWATER trial for patients with metastatic colorectal cancer carrying a BRAF V600E mutation. In this study, the combination of BRAFTOVI (encorafenib), cetuximab (Erbitux®), and mFOLFOX6 showed a much higher objective response rate of about 61% compared to 40% with standard chemotherapy. These results suggest that the targeted treatment nearly doubles the likelihood of reducing or controlling the tumor in affected patients.
The findings have important implications as they support the potential of this combination as a new first-line option for individuals with this aggressive form of cancer. Pfizer plans to share further details at an upcoming clinical oncology conference, and additional survival data are expected later, which could solidify its role in improving patient outcomes.
Read Announcement
BRAFTOVI® + MEKTOVI - FDA Regulatory Timeline and Events
BRAFTOVI® + MEKTOVI is a drug developed by Pfizer for the following indication: For the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.
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:
- BRAFTOVI® + MEKTOVI
- Announced Date:
- September 14, 2024
- Indication:
- For the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation
Announcement
Pfizer Inc announced longer-term follow-up results from the Phase 2 single-arm PHAROS clinical trial evaluating the efficacy and safety of BRAFTOVI® (encorafenib) in combination with MEKTOVI® (binimetinib) for patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC).
AI Summary
Pfizer Inc. recently announced longer-term follow-up results from its Phase 2 single‐arm PHAROS clinical trial. The study evaluated the combination of BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) in patients with BRAF V600E-mutant metastatic non-small cell lung cancer (NSCLC). The trial aimed to assess the efficacy and safety of this targeted treatment in a patient group with an aggressive form of lung cancer, where treatment options are limited.
The longer-term data showed promising response rates along with a manageable safety profile, suggesting that the combination therapy could offer a new option for patients with this specific mutation. Pfizer’s announcement highlights its commitment to advancing new therapeutic approaches through continued clinical research, addressing a significant unmet need in the treatment of metastatic NSCLC.
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CABOTEGRAVIR - FDA Regulatory Timeline and Events
CABOTEGRAVIR is a drug developed by Pfizer for the following indication: FOR PREVENTION OF HIV.
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:
- CABOTEGRAVIR
- Announced Date:
- March 5, 2025
- Indication:
- FOR PREVENTION OF HIV
Announcement
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi as shareholders, is pleased to announce that Quebec has become the first province to publicly reimburse APRETUDE (cabotegravir tablets and extended release injectable suspension) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk individuals who are HIV-1 negative.1
AI Summary
ViiV Healthcare announced that Quebec has become the first province to publicly reimburse APRETUDE for pre-exposure prophylaxis (PrEP). APRETUDE, available as cabotegravir tablets and an extended-release injectable, is now listed under Quebec’s public drug plan (RAMQ). This approval aims to reduce the risk of sexually acquired HIV-1 infection among HIV-1 negative individuals who are at risk and is a significant development in combating rising HIV cases in the province.
The decision by the Quebec government provides at-risk adults and adolescents with more options for HIV prevention. ViiV Healthcare applauds the move, noting its potential to improve access to this long-acting injectable treatment. As HIV rates continue to climb, this initiative represents a proactive step toward better prevention and health outcomes in Quebec.
Read Announcement
CIFFREO - FDA Regulatory Timeline and Events
CIFFREO is a drug developed by Pfizer for the following indication: In ambulatory patients with Duchenne muscular dystrophy (DMD).
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:
- CIFFREO
- Announced Date:
- June 12, 2024
- Indication:
- In ambulatory patients with Duchenne muscular dystrophy (DMD)
Announcement
Pfizer Inc. announced that CIFFREO, a Phase 3 global, multicenter, randomized, double-blind, placebo-controlled study evaluating the investigational mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD) did not meet its primary endpoint of improvement in motor function among boys 4 to 7 years of age treated with the gene therapy compared to placebo.
Read Announcement
COMIRNATY® JN.1 - FDA Regulatory Timeline and Events
COMIRNATY® JN.1 is a drug developed by Pfizer for the following indication: monovalent COVID-19 vaccine.
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:
- COMIRNATY® JN.1
- Announced Date:
- June 27, 2024
- Indication:
- monovalent COVID-19 vaccine
Announcement
Pfizer Inc and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies' Omicron JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY® JN.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.
AI Summary
Pfizer Inc. and BioNTech SE announced that the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) has recommended marketing authorization for their Omicron JN.1-adapted monovalent COVID-19 vaccine, COMIRNATY® JN.1. This updated vaccine is designed to protect individuals aged 6 months and older from COVID-19 caused by the SARS‑CoV‑2 virus, specifically targeting the emerging Omicron JN.1 variant and its sublineages.
The recommendation is based on pre-clinical and epidemiological data, which showed that the JN.1-adapted vaccine produces an improved immune response compared to previous formulations. Once the European Commission grants final authorization, doses will be ready for immediate shipment to applicable EU member states, ensuring swift availability as the vaccination campaign for the 2024-2025 season ramps up.
Read Announcement
danuglipron - FDA Regulatory Timeline and Events
danuglipron is a drug developed by Pfizer for the following indication: Glucagon-like peptide-1 antagonists.
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:
- danuglipron
- Announced Date:
- July 11, 2024
- Indication:
- Glucagon-like peptide-1 antagonists.
Announcement
Pfizer Inc announced that based on results from the ongoing pharmacokinetic study (NCT06153758), the company has selected its preferred once-daily modified release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist.
AI Summary
Pfizer has announced that it has selected its preferred once-daily modified release formulation for danuglipron, an oral GLP-1 receptor agonist, based on encouraging results from an ongoing pharmacokinetic study (NCT06153758). This new formulation is designed to be taken once a day, potentially offering a more convenient treatment option for people requiring GLP-1 therapies. The study compared several modified release formulations and identified one candidate with a promising pharmacokinetic profile, paving the way for further development.
Looking ahead, Pfizer plans to begin dose optimization studies in the second half of 2024. These studies will evaluate multiple doses of the preferred formulation to help support registration-enabling studies. The focus is on advancing danuglipron into later-stage trials to meet significant medical needs, particularly in the area of obesity treatment.
Read Announcement- Drug:
- danuglipron
- Announced Date:
- July 11, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- 2024-H2
- Indication:
- Glucagon-like peptide-1 antagonists.
Announcement
Pfizer plans to conduct dose optimization studies in the second half of 2024 evaluating multiple doses of the preferred modified release formulation to inform the registration enabling studies.
AI Summary
Pfizer has selected its preferred once-daily modified release formulation for danuglipron, an investigational oral GLP-1 receptor agonist aimed at addressing obesity. Based on encouraging pharmacokinetic data from an ongoing study, the new formulation is showing promise for a simpler dosing schedule compared to the twice-daily version.
To further explore its potential, Pfizer plans to conduct dose optimization studies in the second half of 2024. These studies will evaluate multiple doses of this favored formulation. The goal is to gather data that will help support future registration enabling studies. This step is an important part of Pfizer’s strategy to make danuglipron a competitive option in treating obesity, by ensuring it meets both safety and efficacy standards before seeking regulatory approval.
Read Announcement
Dovato - FDA Regulatory Timeline and Events
Dovato is a drug developed by Pfizer for the following indication: For adolescents living with HIV.
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:
- Dovato
- Announced Date:
- July 31, 2024
- Indication:
- For adolescents living with HIV
Announcement
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announced the 48-week findings from PASO DOBLE (GeSIDA 11720 study), the largest head-to-head, phase IV randomized clinical trial (RCT) investigating the 2-drug regimen DOVATO (dolutegravir/lamivudine [DTG/[3TC]) compared to the 3-drug regimen BIKTARVY (bictegravir/emtricitabine]/tenofovir alafenamide fumarate [BIC/FTC/TAF]) for the treatment of HIV-1 in people who are virologically suppressed and who could benefit from treatment optimization.2
AI Summary
ViiV Healthcare, a global HIV specialist company majority owned by GSK with Pfizer and Shionogi as shareholders, announced the 48-week results from the PASO DOBLE (GeSIDA 11720) clinical trial. This phase IV randomized study is the largest head-to-head trial comparing the 2-drug regimen DOVATO (dolutegravir/lamivudine) with the 3-drug regimen BIKTARVY (bictegravir/emtricitabine/tenofovir alafenamide) in people living with HIV who are already virologically suppressed. The trial demonstrated that switching to DTG/3TC maintained viral suppression at rates that were non-inferior to BIC/FTC/TAF while also showing significantly less weight gain. These findings support the potential benefits of treatment optimization for people living with HIV, addressing not only the need for effective viral control but also concerns about weight gain associated with certain HIV therapies.
Read Announcement- Drug:
- Dovato
- Announced Date:
- July 23, 2024
- Indication:
- For adolescents living with HIV
Announcement
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announces 48-week findings from PASO DOBLE (GeSIDA 11720 study), the largest head-to-head, phase IV randomised clinical trial (RCT) investigating the 2-drug regimen Dovato (dolutegravir/lamivudine [DTG/3TC]) compared to the 3-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate [BIC/FTC/TAF]) for the treatment of HIV-1 in people who are virologically suppressed and who could benefit from treatment optimisation.1
AI Summary
ViiV Healthcare announced 48-week results from the PASO DOBLE study, a large head-to-head trial comparing the two-drug regimen Dovato (dolutegravir/lamivudine) with the three-drug regimen Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate) for treating HIV-1 in people who have maintained viral suppression. The study showed that Dovato is non-inferior in maintaining viral suppression compared to Biktarvy. Moreover, participants on Dovato experienced significantly less weight gain than those on Biktarvy. These findings come from a phase IV trial that included 553 participants switching from regimens that could be optimized. The results emphasize the benefits of a two-drug regimen, which not only maintains effective viral control but also may help reduce treatment-related weight gain. The data will be presented at the 25th International AIDS Conference in Munich this July.
Read Announcement- Drug:
- Dovato
- Announced Date:
- April 8, 2024
- Indication:
- For adolescents living with HIV
Announcement
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders announced the U.S. Food and Drug Administration (FDA) approved Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV)
AI Summary
ViiV Healthcare, a global specialist in HIV treatment and majority-owned by GSK with Pfizer and Shionogi as shareholders, announced that the U.S. FDA has approved Dovato (dolutegravir/lamivudine) for treating HIV-1 infection in adolescents. The approval applies to patients aged 12 and older, weighing at least 25 kg, who are either starting antiretroviral therapy for the first time or switching from another regimen while maintaining viral suppression.
Dovato is now the first and only oral, two-drug, single-tablet regimen available for adolescents with HIV. This development addresses the urgent need for additional treatment options among young people, a group significantly affected by new HIV diagnoses. ViiV Healthcare’s commitment to expanding therapeutic choices supports better long-term health outcomes for adolescents living with HIV.
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Elranatamab - FDA Regulatory Timeline and Events
Elranatamab is a drug developed by Pfizer for the following indication: B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb).
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:
- Elranatamab
- Announced Date:
- June 14, 2024
- Indication:
- B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb).
Announcement
Pfizer Inc announced detailed overall survival (OS) results from the Phase 2 MagnetisMM-3 study of ELREXFIO™ (elranatamab-bcmm) in patients with heavily pretreated relapsed or refractory multiple myeloma (RRMM).
AI Summary
Pfizer Inc. announced key overall survival (OS) results from the Phase 2 MagnetisMM-3 study evaluating ELREXFIO™ (elranatamab-bcmm) in patients with heavily pretreated relapsed or refractory multiple myeloma. In this study, patients in cohort A showed a median OS of 24.6 months, highlighting the potential benefit of this bispecific antibody therapy. The trial also reported a median progression‐free survival (PFS) of 17.2 months, supporting the promise of ELREXFIO in offering prolonged disease control for a patient group with limited treatment options. The data demonstrate deep and durable responses, with the overall response rate at 61% and many patients achieving complete responses. These compelling findings reinforce ELREXFIO’s potential as a transformative treatment for multiple myeloma and will be presented at the European Hematology Association's Hybrid Congress in Madrid.
Read Announcement- Drug:
- Elranatamab
- Announced Date:
- June 14, 2024
- Indication:
- B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody (BsAb).
Announcement
Pfizer Inc announced detailed overall survival (OS) results from the Phase 2 MagnetisMM-3 study of ELREXFIO™ (elranatamab-bcmm) in patients with heavily pretreated relapsed or refractory multiple myeloma (RRMM).
AI Summary
Pfizer announced updated overall survival results from the Phase 2 MagnetisMM-3 study of ELREXFIO™ (elranatamab-bcmm) in patients with heavily pretreated relapsed or refractory multiple myeloma. In cohort A of the single-arm trial, the study demonstrated a median overall survival of 24.6 months, while median progression-free survival was 17.2 months. These findings, presented at the European Hematology Association Hybrid Congress in Madrid, highlight ELREXFIO's potential as a transformative treatment option for patients with limited therapeutic alternatives. The data showcase deep and durable responses in a challenging patient population. Pfizer believes that these promising results further support the clinical benefit of ELREXFIO in relapsed or refractory multiple myeloma, reinforcing its position in the evolving landscape of advanced cancer care.
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EMBLAVEO - FDA Regulatory Timeline and Events
EMBLAVEO is a drug developed by Pfizer for the following indication: In the treatment of adult patients with complicated intra-abdominal infections (cIAI).
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:
- EMBLAVEO
- Announced Date:
- February 7, 2025
- Indication:
- In the treatment of adult patients with complicated intra-abdominal infections (cIAI)
Announcement
AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved EMBLAVEO™ (aztreonam and avibactam), as the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic.
AI Summary
AbbVie announced that the U.S. FDA has approved EMBLAVEO™ (aztreonam and avibactam), marking it as the first and only fixed-dose, intravenous monobactam/β-lactamase inhibitor combination antibiotic. This new treatment is designed exclusively for adults who have limited or no alternative options for complicated intra-abdominal infections. It is used alongside metronidazole to target tough Gram-negative bacteria known for their ability to develop resistance to standard antimicrobial therapies.
EMBLAVEO’s approval is based on limited clinical data, yet it represents a promising option in the battle against drug-resistant infections. By combining aztreonam with avibactam, the drug works to protect its active component against bacterial enzymes that would otherwise render it ineffective, offering hope for patients facing challenging, multi-drug-resistant infections.
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EV-302 - FDA Regulatory Timeline and Events
EV-302 is a drug developed by Pfizer for the following indication: For the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- EV-302
- Announced Date:
- February 10, 2025
- Indication:
- For the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC)
Announcement
Pfizer Inc and Astellas Pharma Inc announced additional follow-up results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) evaluating the efficacy and safety of PADCEV® (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, plus KEYTRUDA® (pembrolizumab), a PD-1 inhibitor, in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).
AI Summary
Pfizer Inc. and Astellas Pharma have shared new follow-up results from the Phase 3 EV-302 (KEYNOTE-A39) clinical trial. The study evaluated PADCEV® (enfortumab vedotin-ejfv), a Nectin-4 targeted antibody-drug conjugate, used together with KEYTRUDA® (pembrolizumab), a PD-1 inhibitor, in patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). With a median follow-up of nearly 30 months, the combination treatment showed strong and lasting benefits, doubling both overall survival and progression-free survival compared to chemotherapy. No new safety concerns were observed. These encouraging data reinforce the potential of the PADCEV plus KEYTRUDA combination as a new standard of care for first‐line treatment in patients with advanced urothelial cancer.
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Fidanacogene Elaparvovec - FDA Regulatory Timeline and Events
Fidanacogene Elaparvovec is a drug developed by Pfizer for the following indication: Hemophilia B gene therapy.
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:
- Fidanacogene Elaparvovec
- Announced Date:
- April 26, 2024
- Indication:
- Hemophilia B gene therapy
Announcement
Pfizer Says U.S. FDA Approved Company's BEQVEZ (fidanacogene elaparvovec-dzkt), A One-Time Gene Therapy For Adults With Hemophilia B; Company Now Plans Launching An Innovative Warranty Program Based On Durability Of Patient Response To Treatment
AI Summary
Pfizer has announced that the U.S. Food and Drug Administration approved the company’s BEQVEZ (fidanacogene elaparvovec-dzkt), a one‐time gene therapy specifically designed for adults with hemophilia B. This approval represents a major step forward for gene therapy, offering a treatment that could lessen the lifelong need for regular replacement therapies. The therapy works by addressing the underlying genetic deficiency, aiming to provide patients with a long-term clinical benefit and improved quality of life.
In addition to the approval, Pfizer plans to launch an innovative warranty program based on the durability of patient response to treatment. This pioneering warranty program is designed to assure patients and healthcare providers alike that the benefits of BEQVEZ are sustained over time. The initiative underlines Pfizer’s commitment to advancing personalized medicine and ensuring long-lasting outcomes for those living with hemophilia B.
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giroctocogene fitelparvovec - FDA Regulatory Timeline and Events
giroctocogene fitelparvovec is a drug developed by Pfizer for the following indication: For the treatment of adults with moderately severe to severe hemophilia A.
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:
- giroctocogene fitelparvovec
- Announced Date:
- December 30, 2024
- Indication:
- For the treatment of adults with moderately severe to severe hemophilia A.
Announcement
Sangamo Therapeutics, Inc announced it will regain development and commercialization rights to giroctocogene fitelparvovec, an investigational gene therapy product candidate for the treatment of adults with moderately severe to severe hemophilia A that it has co-developed with, and licensed to Pfizer Inc., following a decision by Pfizer to terminate the global collaboration and license agreement between the parties. Sangamo intends to explore all options to advance the program, including seeking a potential new collaboration partner.
AI Summary
Sangamo Therapeutics announced that it will regain development and commercialization rights to giroctocogene fitelparvovec, an investigational gene therapy for adults with moderately severe to severe hemophilia A. The treatment was co-developed with Pfizer, which recently terminated the global collaboration and license agreement. Pfizer decided not to proceed with the Biologics License Application and Marketing Authorisation Application submissions despite the therapy’s positive Phase 3 AFFINE trial results that met both primary and secondary endpoints. Sangamo expressed disappointment over Pfizer’s decision but remains committed to advancing the program. The company plans to explore every option, including seeking a new collaboration partner, to further develop the asset and move it toward regulatory submission. Sangamo is optimistic that regaining full control of the therapy will help pave the way for a robust development program and ultimately bring a potentially life-changing treatment to patients.
Read Announcement- Drug:
- giroctocogene fitelparvovec
- Announced Date:
- July 24, 2024
- Indication:
- For the treatment of adults with moderately severe to severe hemophilia A.
Announcement
Pfizer Inc. announced positive topline results from the Phase 3 AFFINE study (NCT04370054) evaluating giroctocogene fitelparvovec, an investigational gene therapy for the treatment of adults with moderately severe to severe hemophilia A.
AI Summary
Pfizer announced positive topline results from the Phase 3 AFFINE study evaluating giroctocogene fitelparvovec, an investigational gene therapy for adults with moderately severe to severe hemophilia A. The study met its primary endpoint by showing non-inferiority to standard Factor VIII prophylaxis, and it demonstrated superiority with a significant reduction in the annualized bleeding rate. After a single infusion, the mean bleeding rate dropped from 4.73 before treatment to 1.24 post-infusion, with a one-sided p-value of 0.0040.
Key secondary endpoints were also met, with 84% of patients maintaining FVIII activity above 5% at 15 months, and showing a 98.3% reduction in treated bleeding events. Giroctocogene fitelparvovec was generally well tolerated, offering a promising one-time treatment option that may reduce the need for routine prophylactic infusions, ultimately lessening the treatment burden for patients with hemophilia A.
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HYMPAVZI - FDA Regulatory Timeline and Events
HYMPAVZI is a drug developed by Pfizer for the following indication: For the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors.
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:
- HYMPAVZI
- Announced Date:
- June 26, 2025
- Indication:
- For the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors
Announcement
Pfizer Inc. announced positive topline results from the Phase 3 BASIS study (NCT03938792) evaluating HYMPAVZI™ (marstacimab) for adults and adolescents living with hemophilia A or B with inhibitors.
AI Summary
Pfizer recently announced positive topline results from the Phase 3 BASIS study evaluating HYMPAVZI™ (marstacimab) in adults and adolescents with hemophilia A or B who have inhibitors. The study met its primary endpoint by showing that once‐weekly subcutaneous injections of HYMPAVZI significantly reduced the annual bleeding rate compared to on-demand treatment—achieving a 93% reduction in treated bleeds over a 12-month period. This approach not only improved outcomes across various bleeding measures, including spontaneous, joint, and target bleeds, but also offered a manageable and convenient treatment regimen with minimal preparation.
HYMPAVZI was generally well tolerated, with no reported deaths or thromboembolic events. Pfizer plans to discuss these findings with regulatory authorities, aiming to bring this promising treatment option to patients with inhibitors who currently face limited prophylactic choices.
Read Announcement- Drug:
- HYMPAVZI
- Announced Date:
- November 20, 2024
- Indication:
- For the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors
Announcement
Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for HYMPAVZI™ (marstacimab) for the routine prophylaxis of bleeding episodes in patients 12 years of age and older weighing at least 35 kg with severe hemophilia A
AI Summary
Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for HYMPAVZI™ (marstacimab) for the routine prophylaxis of bleeding episodes in patients 12 years and older who weigh at least 35 kg and have severe hemophilia A without factor VIII inhibitors, or severe hemophilia B without factor IX inhibitors. This approval marks a significant advancement in treatment options for people living with hemophilia.
HYMPAVZI™ is the first anti-tissue factor pathway inhibitor (anti-TFPI) approved in the European Union, and it offers a convenient once-weekly subcutaneous dosing schedule via a pre-filled pen or syringe. Based on positive Phase 3 study results that demonstrated non-inferiority and superiority compared to routine prophylaxis, this breakthrough treatment could help reduce the treatment burden and improve quality of life for eligible patients.
Read Announcement- Drug:
- HYMPAVZI
- Announced Date:
- October 11, 2024
- Indication:
- For the Treatment of Adults and Adolescents with Hemophilia A or B Without Inhibitors
Announcement
Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) has approved HYMPAVZI™ (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients 12 years of age and older with hemophilia A (congenital factor VIII deficiency) without factor VIII (FVIII) inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX (FIX) inhibitors.
AI Summary
The U.S. Food and Drug Administration (FDA) has approved Pfizer’s HYMPAVZI™ (marstacimab-hncq) for routine prophylaxis to reduce or prevent bleeding episodes in patients aged 12 and older with hemophilia A (factor VIII deficiency) without factor VIII inhibitors, and those with hemophilia B (factor IX deficiency) without factor IX inhibitors. This approval introduces a novel treatment option that uses a once-weekly subcutaneous injection administered by a pre-filled auto-injector pen, making it easier to use compared to traditional frequent intravenous infusions.
Clinical trials demonstrated that HYMPAVZI significantly reduces overall bleeding incidents compared to routine prophylaxis and on-demand treatments. Its convenient dosing schedule and straightforward administration aim to lessen the treatment burden and improve the quality of life for patients living with hemophilia. This new option represents an important advancement in hemophilia care for both adults and adolescents.
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LORBRENA (lorlatinib) - FDA Regulatory Timeline and Events
LORBRENA (lorlatinib) is a drug developed by Pfizer for the following indication: anaplastic lymphoma kinase (ALK)-positive 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:
- LORBRENA (lorlatinib)
- Announced Date:
- May 31, 2024
- Indication:
- anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC)
Announcement
Pfizer Inc. announced longer-term follow-up results from the Phase 3 CROWN trial evaluating LORBRENA® (lorlatinib, a third-generation ALK inhibitor, available in Europe under the brand name LORVIQUA®) versus XALKORI® (crizotinib) in people with previously untreated, anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
AI Summary
Pfizer Inc. has announced longer-term follow-up results from its Phase 3 CROWN trial, which compared LORBRENA® (lorlatinib) with XALKORI® (crizotinib) in patients with previously untreated, ALK-positive advanced non-small cell lung cancer (NSCLC). After a median follow-up of five years, the study showed that patients taking LORBRENA experienced significant benefits. The median progression-free survival was not reached with LORBRENA, corresponding to an 81% reduction in the risk of disease progression or death compared to XALKORI. Impressively, 60% of patients on LORBRENA remained alive without disease progression after five years, versus only 8% on XALKORI. The trial also demonstrated a 94% reduction in the risk of developing brain metastases among patients receiving LORBRENA. These results highlight LORBRENA as a strong first-line treatment option for ALK-positive advanced NSCLC, providing long-term benefits for patients.
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LORVIQUA (lorlatinib) - FDA Regulatory Timeline and Events
LORVIQUA (lorlatinib) is a drug developed by Pfizer for the following indication: Anaplastic lymphoma kinase (ALK)- positive advanced 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:
- LORVIQUA (lorlatinib)
- Announced Date:
- May 31, 2024
- Indication:
- Anaplastic lymphoma kinase (ALK)- positive advanced non-small cell lung cancer (NSCLC)
Announcement
Pfizer Inc announced longer-term follow-up results from the Phase 3 CROWN trial evaluating LORBRENA® (lorlatinib, a third-generation ALK inhibitor, available in Europe under the brand name LORVIQUA®) versus XALKORI® (crizotinib) in people with previously untreated, anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
AI Summary
Pfizer recently announced longer-term results from the Phase 3 CROWN trial, which compares LORBRENA® (lorlatinib) with XALKORI® (crizotinib) in patients with previously untreated, ALK‑positive advanced non‑small cell lung cancer (NSCLC). After a median follow‑up of five years, the data revealed that 60% of patients treated with LORBRENA were alive without disease progression, an unprecedented outcome in this setting. The trial showed an 81% reduction in the risk of progression or death with LORBRENA compared to XALKORI. Notably, LORBRENA also reduced the risk of brain metastases by 94%, offering significant protection against intracranial progression. These results suggest that LORBRENA could provide sustained benefits as a first‑line treatment option for patients with ALK‑positive advanced NSCLC.
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mRNA vaccine - FDA Regulatory Timeline and Events
mRNA vaccine is a drug developed by Pfizer for the following indication: Against influenza and COVID-19 in healthy individuals 18-64 years of age.
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:
- mRNA vaccine
- Announced Date:
- August 16, 2024
- Indication:
- Against influenza and COVID-19 in healthy individuals 18-64 years of age.
Announcement
Pfizer Inc. and BioNTech SE announced top-line results from their Phase 3 clinical trial to evaluate the companies' combined mRNA vaccine candidate against influenza and COVID-19 in healthy individuals 18-64 years of age.
AI Summary
Pfizer Inc. and BioNTech SE recently announced top-line results from their Phase 3 clinical trial evaluating a combined mRNA vaccine candidate for both influenza and COVID-19 in healthy individuals aged 18-64. In this study, which involved more than 8,000 participants, the vaccine met one of its two primary immunogenicity goals. It produced comparable immune responses against COVID-19 and robust responses to influenza A when compared to standard vaccines. However, the candidate did not meet the non-inferiority goal for the influenza B strain. The companies are now considering adjustments to enhance the vaccine’s effectiveness against influenza B and will discuss next steps with health authorities. No safety concerns have been reported in the ongoing data review, highlighting a positive direction for the development of an efficient combination vaccine.
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Omicron KP.2 - FDA Regulatory Timeline and Events
Omicron KP.2 is a drug developed by Pfizer for the following indication: For Omicron KP.2-adapted COVID-19 Vaccine.
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:
- Omicron KP.2
- Announced Date:
- August 22, 2024
- Indication:
- For Omicron KP.2-adapted COVID-19 Vaccine
Announcement
Pfizer Inc. and BioNTech SE announced that the U.S. Food and Drug Administration ("FDA") has approved the supplemental Biologics License Application for individuals 12 years of age and older (COMIRNATY® (COVID-19 Vaccine, mRNA)), and granted emergency use authorization for individuals 6 months through 11 years of age (Pfizer-BioNTech COVID-19 Vaccine) of the companies' Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine.
AI Summary
Pfizer Inc. and BioNTech SE announced that the FDA has approved the supplemental Biologics License Application for COMIRNATY® (COVID-19 Vaccine, mRNA) for individuals 12 years and older. The FDA also granted emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine for children 6 months to 11 years old. This updated vaccine is designed to protect against the Omicron KP.2 strain and is the preferred approach for the 2024-2025 fall and winter season, following FDA guidance. For most people 5 years and older, the vaccine is administered as a single dose. The decision is backed by extensive clinical, non-clinical, and real-world evidence showing that the updated formulation elicits a strong immune response and improved protection against emerging strains. Shipping has already begun to ensure widespread availability in pharmacies, hospitals, and clinics nationwide.
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Oxbryta (voxelotor) - FDA Regulatory Timeline and Events
Oxbryta (voxelotor) is a drug developed by Pfizer for the following indication: Sickle Cell Disease in Children Ages 4 to 11.
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:
- Oxbryta (voxelotor)
- Announced Date:
- September 25, 2024
- Indication:
- Sickle Cell Disease in Children Ages 4 to 11
Announcement
Pfizer Inc. announced that it is voluntarily withdrawing all lots of OXBRYTA® (voxelotor) for the treatment of sickle cell disease (SCD) at this time, in all markets where it is approved. Pfizer is also discontinuing all active voxelotor clinical trials and expanded access programs worldwide.
AI Summary
Pfizer Inc. announced that it is voluntarily withdrawing all lots of OXBRYTA® (voxelotor) for treating sickle cell disease in every approved market. The company is also stopping all ongoing voxelotor clinical trials and expanded access programs worldwide. This decision follows new clinical data that shows the benefits of the drug no longer outweigh its risks, especially given an imbalance in vaso-occlusive crises and fatal events. Pfizer has informed regulatory authorities about these findings and is reviewing the data carefully. The firm emphasized that patient safety is its top priority and advised patients with sickle cell disease to contact their doctors for alternative treatment options. Despite the withdrawal, Pfizer does not expect this step to affect its overall financial guidance for 2024.
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palbociclib - FDA Regulatory Timeline and Events
palbociclib is a drug developed by Pfizer for the following indication: In Patients With HR+, HER2+ Metastatic Breast 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:
- palbociclib
- Announced Date:
- December 12, 2024
- Indication:
- In Patients With HR+, HER2+ Metastatic Breast Cancer
Announcement
Pfizer Inc announced results from the Phase 3 PATINA trial demonstrating that the addition of IBRANCE® (palbociclib) to current standard-of-care first-line maintenance therapy (following induction chemotherapy) resulted in statistically significant and clinically meaningful improvement in progression-free survival (PFS) by investigator assessment in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC).
AI Summary
Pfizer announced promising results from the Phase 3 PATINA trial, which studied the addition of IBRANCE® (palbociclib) to the standard first-line maintenance therapy for patients with hormone receptor-positive (HR+), HER2-positive metastatic breast cancer. The trial showed that patients receiving IBRANCE with anti-HER2 therapy (trastuzumab or trastuzumab plus pertuzumab) and endocrine therapy had a median progression-free survival (PFS) of 44.3 months compared to 29.1 months in patients who did not receive IBRANCE. This improvement of over 15 months was statistically significant and clinically meaningful, with a hazard ratio of 0.74 and a one-sided p-value of 0.0074.
These results mark the first large Phase 3 study to demonstrate the benefit of adding a CDK4/6 inhibitor like IBRANCE in HR+, HER2+ metastatic breast cancer, suggesting that this combination could potentially slow disease progression and improve outcomes in this challenging patient population.
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ponsegromab - FDA Regulatory Timeline and Events
ponsegromab is a drug developed by Pfizer for the following indication: In Patients with Cancer Cachexia.
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:
- ponsegromab
- Announced Date:
- September 14, 2024
- Indication:
- In Patients with Cancer Cachexia
Announcement
Pfizer Inc announced its Phase 2 study of ponsegromab, a monoclonal antibody directed against growth differentiation factor-15 (GDF-15), met its primary endpoint of change from baseline in body weight compared to placebo in people with cancer cachexia and elevated levels of GDF-15.
AI Summary
Pfizer Inc. announced promising Phase 2 results for ponsegromab, a monoclonal antibody aimed at blocking growth differentiation factor-15 (GDF-15) in patients with cancer cachexia. The study met its primary endpoint, showing significant increases in body weight compared to placebo. Notably, patients receiving the highest dose (400 mg) experienced a mean body weight increase of 5.6% after 12 weeks. In addition to the weight gain, improvements in appetite, cachexia symptoms, physical activity, and muscle mass were observed at this dose, and the treatment was generally safe and well-tolerated. The trial involved 187 cancer patients, including those with non-small cell lung, pancreatic, or colorectal cancer, who had elevated levels of GDF-15. Based on these encouraging findings, registration-enabling studies are planned to start in 2025, marking a significant step toward addressing cancer cachexia.
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sasanlimab - FDA Regulatory Timeline and Events
sasanlimab is a drug developed by Pfizer for the following indication: In patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).
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:
- sasanlimab
- Announced Date:
- April 26, 2025
- Indication:
- In patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).
Announcement
Pfizer Inc. announced results from the pivotal Phase 3 CREST trial of sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with standard of care (SOC) Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).
AI Summary
Pfizer Inc. announced promising results from the pivotal Phase 3 CREST trial, testing sasanlimab—an investigational anti-PD-1 monoclonal antibody—in combination with standard Bacillus Calmette-Guérin (BCG) therapy. In this trial, patients with high-risk, non-muscle invasive bladder cancer who had not previously received BCG showed a 32% reduction in the risk of disease-related events. These events included high-grade disease recurrence or progression. The trial met its primary endpoint of event-free survival, with a hazard ratio of 0.68 demonstrating statistically significant improvement over BCG alone. Sasanlimab is given as a subcutaneous injection every four weeks and is evaluated both as induction therapy and with maintenance BCG. The results from this study mark a potential breakthrough, offering a new treatment option for patients with bladder cancer—a field that has seen little advancement in over 30 years.
Read Announcement- Drug:
- sasanlimab
- Announced Date:
- January 10, 2025
- Indication:
- In patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).
Announcement
Pfizer Inc announced positive topline results from its pivotal Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody (mAb), in combination with Bacillus Calmette-Guérin (BCG) as induction therapy with or without maintenance in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).
AI Summary
Pfizer Inc. announced positive topline results from the Phase 3 CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody, for patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC). In the trial, sasanlimab was given in combination with Bacillus Calmette-Guérin (BCG) as induction therapy, with some patients also receiving maintenance treatments. The study met its primary endpoint by showing a meaningful and statistically significant improvement in event-free survival compared to BCG alone. This combination therapy could reduce recurrence and delay the need for more aggressive treatments, addressing a significant unmet need in this patient population. Pfizer plans to discuss these promising data with global health authorities to support potential regulatory filings, and if approved, sasanlimab may become the first PD-1 inhibitor paired with BCG to provide improved treatment outcomes for NMIBC patients.
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TALZENNA - FDA Regulatory Timeline and Events
TALZENNA is a drug developed by Pfizer for the following indication: Oral inhibitor of poly ADP-ribose polymerase.
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:
- TALZENNA
- Announced Date:
- October 10, 2024
- Indication:
- Oral inhibitor of poly ADP-ribose polymerase
Announcement
Pfizer Inc announced positive topline results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), an androgen receptor pathway inhibitor (ARPI), in patients with metastatic castration-resistant prostate cancer (mCRPC).
AI Summary
Pfizer announced positive topline results from the final overall survival analysis of the Phase 3 TALAPRO-2 study. In this trial, patients with metastatic castration-resistant prostate cancer (mCRPC) received TALZENNA (talazoparib), an oral PARP inhibitor, in combination with XTANDI (enzalutamide), an androgen receptor pathway inhibitor. The study showed a statistically significant and clinically meaningful improvement in overall survival compared with XTANDI alone, benefiting both all patients and those with HRR gene mutations. This combination is the first of its kind—pairing a PARP inhibitor with an ARPI—to demonstrate such a survival benefit in mCRPC. Pfizer plans to submit the data to global health authorities to potentially update TALZENNA’s label, reinforcing the company’s commitment to advancing new treatments and improving survival outcomes for men with advanced prostate cancer.
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TIVDAK - FDA Regulatory Timeline and Events
TIVDAK is a drug developed by Pfizer for the following indication: For Patients with Recurrent or Metastatic 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:
- TIVDAK
- Announced Date:
- March 31, 2025
- Indication:
- For Patients with Recurrent or Metastatic Cervical Cancer
Announcement
Genmab A/S announced today that the European Commission (EC) has granted marketing authorization for TIVDAK® (tisotumab vedotin), an antibody-drug conjugate (ADC), as monotherapy treatment for adult patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy.
AI Summary
Genmab A/S announced that the European Commission has granted marketing authorization for TIVDAK® (tisotumab vedotin) as a monotherapy treatment for adult patients with recurrent or metastatic cervical cancer who have experienced disease progression after systemic therapy. This approval marks a significant advancement, as TIVDAK is the first and only antibody-drug conjugate (ADC) approved in the EU for this challenging condition.
Clinical data from the global Phase 3 innovaTV 301 trial showed that TIVDAK led to superior overall survival compared to chemotherapy. The results, including improvements in progression-free survival and response rates, support TIVDAK’s potential to become a new standard of care for advanced cervical cancer. This milestone offers new hope for patients facing limited treatment options and underscores ongoing progress in targeted cancer therapies.
Read Announcement- Drug:
- TIVDAK
- Announced Date:
- January 15, 2025
- Indication:
- For Patients with Recurrent or Metastatic Cervical Cancer
Announcement
Zai Lab Limited announced positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 study, demonstrating a clinically meaningful improvement in overall survival with TIVDAK treatment for patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy.
AI Summary
Zai Lab Limited recently announced positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 study. In this study, TIVDAK treatment showed a clinically meaningful improvement in overall survival compared to chemotherapy among patients with previously treated recurrent or metastatic cervical cancer. The findings include a 45% reduction in the risk of death, and secondary measures like progression-free survival and objective response rate also favored TIVDAK over standard chemotherapy.
The safety profile in the China subpopulation was manageable and consistent with results seen in the broader global study. These promising results support TIVDAK as a potential new treatment option for a patient group with limited effective therapies. Zai Lab plans to submit a New Drug Application to China’s National Medical Products Administration in the first quarter of 2025, and will leverage its existing commercial presence with ZEJULA in women’s cancer to improve patient access if approved.
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VLA15-221 - FDA Regulatory Timeline and Events
VLA15-221 is a drug developed by Pfizer for the following indication: For Lyme Disease Vaccine Candidate.
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:
- VLA15-221
- Announced Date:
- September 3, 2024
- Indication:
- For Lyme Disease Vaccine Candidate
Announcement
Valneva SE VALNVLA and Pfizer Inc. announced positive immunogenicity and safety data from their VLA15-221 Phase 2 study following a second booster vaccination of their Lyme disease vaccine candidate, VLA15, given one year after receiving the first booster dose.
AI Summary
Valneva SE and Pfizer Inc. announced positive results from their VLA15-221 Phase 2 study, highlighting that a second booster dose of the Lyme disease vaccine candidate, VLA15, given one year after the first booster, produces a strong immune response. One month after the second booster, the vaccine generated a significant increase in antibodies against all six targeted serotypes in children, adolescents, and adults. The seroconversion rates were above 90% in all age groups, matching the rates observed after the first booster. The study showed that the second booster has a favorable safety profile, with safety findings consistent with earlier doses. These results support the potential benefit of booster vaccinations before each Lyme season and offer encouraging progress in the pursuit of a vaccine for a disease that remains a significant public health challenge.Read Announcement
XTANDI (Enzalutamide) - FDA Regulatory Timeline and Events
XTANDI (Enzalutamide) is a drug developed by Pfizer for the following indication: Metastatic Hormone-Sensitive 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:
- XTANDI (Enzalutamide)
- Announced Date:
- July 10, 2025
- Indication:
- Metastatic Hormone-Sensitive Prostate Cancer
Announcement
Pfizer Inc. and Astellas Pharma Inc announced positive topline results from the overall survival (OS) analysis from the Phase 3 EMBARK study evaluating XTANDI® (enzalutamide), in combination with leuprolide and as a monotherapy, in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as nonmetastatic castration-sensitive prostate cancer or nmCSPC) with biochemical recurrence (BCR) at high risk for metastasis.
AI Summary
Pfizer Inc. and Astellas Pharma Inc. announced positive overall survival (OS) results from the Phase 3 EMBARK study in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) who have high-risk biochemical recurrence (BCR). The study showed that patients receiving XTANDI® (enzalutamide) combined with leuprolide experienced a statistically significant and clinically meaningful improvement in OS compared to those given placebo plus leuprolide. Although XTANDI used as a monotherapy also showed a favorable trend in improved survival, it did not reach statistical significance.
The safety profile of XTANDI remained consistent, with no new safety signals reported. These findings support the early initiation of XTANDI treatment for patients with nmHSPC and high-risk BCR, offering them a viable option to potentially extend their lives following initial curative treatments such as prostatectomy or radiation therapy.
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