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 | Press Release

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