The US FDA Grants Approval to BeiGene’s Tevimbra to Treat Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Shots:
- BeiGene’s Tevimbra has received the US FDA’s approval as a monotx. to treat unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic chemotherapy (CT) excl. PD-(L)1 inhibitor. The US availability is anticipated in H2’24
- The approval was supported by the P-III (RATIONALE 302) study assessing the safety & efficacy of Tevimbra vs CT for the 2L treatment of unresectable, locally advanced or metastatic ESCC patients (n=512) across the EU, Asia & North America
- The study met the 1EP among the ITT population demonstrating mOS of 8.6mos. vs 6.3mos. with a favorable safety outcome
Ref: BeiGene | Image: BeiGene
Related News:- BeiGene’s Tevimbra (tislelizumab) Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer (NSCLC)
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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.
