06:56 AM EST, 11/27/2024 (MT Newswires) -- BeiGene Ltd ( BGNE ) said Wednesday that the European Commission has approved Tevimbra in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma.

The approval is based on results from BeiGene's ( BGNE ) RATIONALE-306 and RATIONALE-305 phase 3 trials, which evaluated the efficacy and safety of TEVIMBRA in combination with chemotherapy. The studies met their primary endpoints, showing statistically significant and clinically meaningful overall survival benefits compared with placebo.

The company's shares were up over 4% in recent premarket activity on Wednesday.

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