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
Recommendation based on results of Phase 3 CheckMate -9DW clinical trial demonstrating statistically significant and clinically meaningful improvement in overall survival with Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib in this patient population
For people with relapsed or refractory diffuse large B-cell lymphoma
Susvimo is a unique therapeutic approach that provides continuous delivery of medicine to the eye through a refillable implant
Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients
TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer
Sales reflect continued strong growth in oncology and vaccines
If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy
Submission to be reviewed under FDA real-time oncology review and Project Orbis
If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure
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