BeiGene Reports the CHMP’s Positive Opinions for Tevimbra as a 1L Treatment of G/GEJ Cancer and Esophageal Squamous Cell Carcinoma
Shots:
- The CHMP has recommended 1L Tevimbra with Pt & fluoropyrimidine-based CT for PD-L1+, HER2-ve locally advanced unresectable or metastatic G/GEJ cancer & with Pt-based CT for unresectable, locally advanced or metastatic PD-L1+ ESCC
- Opinion for G/GEJ cancer was based on P-III (RATIONALE-305) study in 997 patients, showing mOS of 15mos. vs 12.9mos. leading to 20% reduction in the risk of death. In the PD-L1 ≥5% group, mOS was 16.4mos. vs 12.8mos. reducing the risk of death by 29%
- Opinion for ESCC was based on P-III (RATIONALE-306) study in 649 patients, showing mOS of 17.2mos. vs 10.6mos. leading to 34% reduction in the risk of death. In the PD-L1 ≥5% group, 3yrs. OS was improved with mOS of 19.1mos. vs 10mos. reducing the risk of death by 38%
Ref: Beigene | Image: Beigene
Related News:- The US FDA Grants Approval to BeiGene’s Tevimbra to Treat Advanced or Metastatic 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.
