Oncology company BeiGene Ltd (NASDAQ: BGNE) revealed on Wednesday that it has received European Commission approval for TEVIMBRA (tislelizumab) in combination with chemotherapy for the first-line treatment of advanced esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

This approval is based on positive results from two Phase 3 studies, which demonstrated a statistically significant overall survival (OS) benefit.

In ESCC, TEVIMBRA, combined with platinum-based chemotherapy, showed a 34% reduction in the risk of death compared to placebo (median OS of 17.2 months vs. 10.6 months). In G/GEJ cancer, the combination treatment reduced the risk of death by 20% (median OS of 15.0 months vs. 12.9 months). The safety profile was consistent with previous findings, with common adverse reactions including neutropenia, anemia, and fatigue.

TEVIMBRA, an anti-PD-1 monoclonal antibody, is already approved in the EU for certain metastatic cancers and has been used to treat over 1.3 million patients globally.

The company added that it plans to change its name to BeOne Medicines, reflecting its focus on expanding access to innovative cancer treatments.