Oncology company BeiGene (NASDAQ:BGNE) (HKEX:06160) (SSE:688235) announced on Friday that the US Food and Drug Administration (FDA) has approved TEVIMBRA (tislelizumab-jsgr) in combination with chemotherapy for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumours express PD-L1 (≥1).

This approval was based on the results of the RATIONALE-305 trial, which demonstrated a significant improvement in overall survival for patients treated with TEVIMBRA plus chemotherapy compared to chemotherapy alone.

It is the second FDA approval for TEVIMBRA in 2024.

TEVIMBRA is also approved in the United States for the treatment of esophageal squamous cell carcinoma.

BeiGene recently announced its intent to change its name to BeOne Medicines Ltd.