BeiGene (NASDAQ: BGNE) has announced that its supplementary Biologic License Application (sBLA) for the programmed death-1 (PD-1) inhibitor tislelizumab has been accepted for review by the Center for Drug Evaluation (CDE) in China. The application seeks approval for the drug to be used in combination with etoposide and chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).
Clinical Study Highlights Superiority of Tislelizumab
The sBLA submission is based on the promising results from the RATIONALE 312 study, which demonstrated that the combination of tislelizumab and chemotherapy provides superior overall survival (OS) outcomes compared to chemotherapy alone in treatment-naïve patients with ES-SCLC. Importantly, no new safety warnings were identified during the study, reinforcing the drug’s safety profile.
Expanding Indications and Global Reach
Tislelizumab has already achieved 11 indication approvals in China, with nine listed in the National Reimbursement Drug List (NRDL). The drug is also awaiting regulatory decisions for first-line treatment in hepatocellular carcinoma and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
Internationally, tislelizumab has received approval for treating advanced or metastatic esophageal squamous cell carcinoma (ESCC) in Europe, and its use is under review in the United States. Additionally, the drug is awaiting approval decisions in Europe for both previously treated and untreated non-small cell lung cancer (NSCLC). Marketing applications have been submitted and accepted for review in several countries, including the UK, Australia, New Zealand, Brazil, South Korea, Switzerland, Israel, and Indonesia.-Fineline Info & Tech
