EC approval for BeiGene’s Tevimbra in ES-SCLC

8 May 2025

Sino-American biotech BeiGene (Nasdaq: ONC; HKEX 06160) today announced that the European Commission has approved Tevimbra (tislelizumab), in combination with etoposide and platinum chemotherapy, as a first-line treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC).

Lung cancer is the leading cause of cancer-related deaths worldwide. SCLC is an aggressive, high-grade cancer that accounts for 15% of all lung cancers, and is typically classified as limited-stage or extensive-stage disease. In Europe, the estimated prevalence of SCLC is 1-5 per 10,000 people.

In addition to ES-SCLC, Tevimbra is approved in the European Union across three non-small lung cancer (NSCLC) indications covering both the first- and second-line settings, as a first-line treatment for eligible patients with unresectable esophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in combination with chemotherapy, and as a second line treatment in unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy.

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