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BeiGene’s Evimbra (tislelizumab) Receives EC’s Approval for Unresectable, Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

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BeiGene’s Evimbra (tislelizumab) Receives EC’s Approval for Unresectable, Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma

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  • 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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Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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