RSS BeiGene Announces FDA Approval Of TEVIMBRA - Quick Facts

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 RSS BeiGene Announces FDA Approval Of TEVIMBRA - Quick Facts

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BeiGene (BGNE) has announced the approval by the FDA of TEVIMBRA, when used in conjunction with platinum and fluoropyrimidine-based chemotherapy, for the frontline treatment of adults with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma exhibiting PD-L1 expression. This new indication for the treatment of first-line G/GEJ cancers stems from findings in BeiGene's RATIONALE-305, an international Phase 3 clinical trial that was randomized, double-blind, and placebo-controlled.

According to Mark Lanasa, Chief Medical Officer, Solid Tumors at BeiGene, "This marks the second U.S. approval for TEVIMBRA this year, highlighting its potential to meet critical needs in oncology treatment."

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