BeiGene announces FDA approval of Tevimbra

BeiGene (BGNE), a global oncology company that intends to change its name to BeOne Medicines, announced the U.S. FDA has approved Tevimbra in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1. Tevimbra is also approved in the U.S. as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-1 inhibitor. An additional Biologics License Application is under review at the FDA for the first-line treatment of adult patients with locally advanced unresectable or metastatic ESCC.