FDA approves BeiGene's drug Tevimbra for advanced esophageal squamous cell carcinoma patients after prior chemotherapy.
BeiGene's drug Tevimbra approved by FDA for advanced or metastatic esophageal squamous cell carcinoma (ESCC) as a monotherapy for adult patients who have received prior systemic chemotherapy. This is the first indication in the US for Tevimbra, which will be available in the US in the second half of 2024. The approval is based on the global Phase 3 RATIONALE 302 trial, which demonstrated that Tevimbra prolonged the survival of patients who received prior systemic treatment compared to chemotherapy.
March 14, 2024
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