BeiGene’s Evimbra (tislelizumab) Receives EC’s Approval for Unresectable, Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Shots:
- The EC has approved Tevimbra as a monotx. for adult patients with unresectable, LA, or metastatic ESCC after prior Pt-based CT. The approval was based on the P-III study (RATIONALE 302) evaluating Tevimbra vs CT in 513 patients from 132 research sites in 11 countries in the EU, Asia & North America
- The trial met its 1EPs in the ITT population with a significant clinical survival benefit, m-OS (8.6 vs 6.3mos.). The safety profile was consistent with prior trials
- Additionally, the US FDA has accepted for review a BLA of tislelizumab as a 1L treatment for unresectable, recurrent, LA, or metastatic ESCC with an anticipated PDUFA date in H2’24. Tislelizumab received ODD from the US FDA for previously untreated advanced or metastatic ESCC
Ref: Businesswire | Image: BeiGene
Related News:- BeiGene to Present P-III Trial (RATIONALE 315) Results of Tislelizumab for Resectable Non-Small Cell Lung Cancer at ESMO Congress 2023
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