Drug Approval | February 13, 2025
FDA approves Pfizer’s ADCETRIS combination regimen for the treatment of Relapsed/Refractory DLBCL
Approval is based on positive data from the Phase 3 ECHELON-3 trial
Approval is based on positive data from the Phase 3 ECHELON-3 trial
BRAFTOVI combination regimen is the first and only targeted therapy approvedby the U.S. FDA for treatment-naïve patients with metastatic colorectal cancer with a BRAF V600E mutation
If approved, sasanlimab would be the first PD-1 inhibitor, in combination with BCG, to significantly prolong event-free survival in this patient population
IBRANCE is the first CDK4/6 inhibitor to show benefit in a large Phase 3 trial in first-line HR+, HER2+ metastatic breast cancer, in combination with anti-HER2 and endocrine therapy
Vepdegestrant in combination with abemaciclib demonstrated encouraging clinical activity (clinical benefit rate
Roger Dansey to become Interim Chief Oncology Officer and Johanna Bendell to join Pfizer as Oncology Chief Development Officer
Detailed data from Phase 3 ECHELON-3 study demonstrate investigational ADCETRIS regimen reduced risk of death by 37 percent compared to chemotherapy alone
Third Phase 3 trial in third type of lymphoma to show improvement in overall survival with an ADCETRIS-containing regimen
At the recommended Phase 3 dose of 200 mg vepdegestrant in combination with palbociclib, patients achieved a median progression-free survival of 13.9 months
Pfizer to discuss regulatory submission with FDA, potentially leading to eighth indication for ADCETRIS
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