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FDA Approves BeiGene’s TEVIMBRA in Esophageal Cancer

Phase 3 trial showed prolonged the survival of patients who received prior systemic treatment compared to chemotherapy.

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By: Kristin Brooks

Managing Editor, Contract Pharma

BeiGene, Ltd., received approval from the U.S. FDA for TEVIMBRA (tislelizumab-jsgr) as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. TEVIMBRA will be available in the U.S. in the second half of 2024.   The approval is based on the RATIONALE 302 trial, which met its primary endpoint in the intention-to-treat (ITT) population with a statistically...

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