Oncology company BeiGene Ltd (NASDAQ: BGNE) (HKEX: 06160) (SSE: 688235) announced on Monday that it has received positive recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for extending the use of TEVIMBRA (tislelizumab) as a first-line treatment for advanced gastric, gastroesophageal junction (G/GEJ) cancer and esophageal squamous cell carcinoma (ESCC).
The decision for G/GEJ adenocarcinoma is based on the RATIONALE-305 trial, which showed TEVIMBRA, in combination with chemotherapy, improved overall survival by 20%, reducing the risk of death compared to placebo.
Similarly, for ESCC, the RATIONALE-306 trial demonstrated a 34% reduction in the risk of death, with TEVIMBRA offering significant survival benefits in combination with chemotherapy.
TEVIMBRA is already approved in the EU for ESCC following platinum-based chemotherapy and various non-small cell lung cancer (NSCLC) treatments. These new approvals further strengthen its presence in the oncology market.
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