FDA approves BeiGene's TEVIMBRA for ESCC after prior chemo; available H2 2024

BeOne Medicines Ltd.

FDA approved TEVIMBRA (tislelizumab) for ESCC after prior chemo; first US indication; available H2 2024.
Approval based on RATIONALE 302: median OS 8.6 vs 6.3 months (HR=0.70, p=0.0001).
FDA also reviewing BLAs for first-line ESCC (target July 2024) and G/GEJ adenocarcinoma (target Dec 2024).
Over 900,000 patients prescribed TEVIMBRA globally; 17+ registration-enabling trials ongoing.
Safety profile favorable over chemo; common adverse reactions include increased glucose, decreased hemoglobin, fatigue.

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