BeiGene (NASDAQ: BGNE) has announced that the US Food and Drug Administration (FDA) has granted approval for its programmed death-1 (PD-1) inhibitor, tislelizumab, as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC). The approval is for patients who have been previously treated with systemic chemotherapy but have not received prior PD-(L)1 inhibitor treatment. Tislelizumab will be marketed under the trade name Tevimbra, with BeiGene preparing for a market launch in the second half of 2024.
The approval is supported by the positive results from the RATIONALE 302 trial, which demonstrated a statistically significant and clinically meaningful survival benefit for Tevimbra compared with chemotherapy in the intention-to-treat (ITT) population. The median overall survival (OS) in the Tevimbra arm was 8.6 months, compared to 6.3 months in the chemotherapy arm, with a hazard ratio (HR) of 0.70. The safety profile of Tevimbra was found to be favorable over chemotherapy.
BeiGene has submitted 15 indication approval filings for tislelizumab to China’s Center for Drug Evaluation (CDE), with 12 approvals granted to date, and 11 of these indications covered by the National Reimbursement Drug List (NRDL). The drug also received approval from the European Commission for advanced or metastatic ESCC after prior chemotherapy in 2023 and a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) in February 2024 for non-small cell lung cancer across three indications.
The FDA is currently reviewing Biologics License Applications (BLAs) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC and for patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, with target action dates set for July and December 2024, respectively.- Flcube.com
