BeiGene Announces FDA Approval Of TEVIMBRA - Quick Facts

(RTTNews) - BeiGene (BGNE) announced the FDA has approved TEVIMBRA, in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1. The additional indication for first-line G/GEJ cancers is based on results from BeiGene's RATIONALE-305, a randomized, double-blind, placebo-controlled, global Phase 3 trial.

Mark Lanasa, Chief Medical Officer, Solid Tumors at BeiGene, said: "This is the second U.S. approval for TEVIMBRA this year, underscoring its potential to address critical needs in oncology."

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