BeiGene’s Tevimbra Plus Chemotherapy Secures the US FDA’s Approval as a 1L Treatment of G/GEJ Cancers
Shots:
- The US FDA has approved Tevimbra + Pt & fluoropyrimidine-based CT as a 1L treatment of inoperable or metastatic HER2- G/GEJ adenocarcinoma with PD-L1 (≥1) expression. Another BLA for 1L locally advanced unresectable or metastatic ESCC is under review
- Approval was based on P-III (RATIONALE-305) study of Tevimbra + CT vs PBO in patients (n=997) that achieved 1EP, showing OS benefits with a 20% reduction in the death risk & mOS of 15 vs 12.9mos.
- Pooled safety analysis included data from 2 studies (RATIONALE-302 & BGB-A317-303) in 1,972 patients plus 5 trials (BGB-A317-208, BGB-A317-204, BGB-A317-203, BGB-A317-102 & BGB A317_Study_001) in patients with ESCC (n=307) & advanced or recurrent tumors (n=1,665)
Ref: BeiGene | Image: BeiGene
Related News:- BeiGene Reports the CHMP’s Positive Opinions for Tevimbra as a 1L Treatment of G/GEJ Cancer and Esophageal Squamous Cell Carcinoma
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
