Bet_Noire
BeiGene (NASDAQ:BGNE) has received FDA approval for its drug Tevimbra in the treatment of advanced or metastatic esophageal squamous cell carcinoma, or ESCC.
The drug, also known as tislelizumab-jsgr, was approved as a monotherapy for patients with unresectable or metastatic ESCC after prior systemic chemotherapy that didn’t include a PD-L1 inhibitor.
Beigene plans to launch Tevimbra in the US in the second half of the year.
The FDA is also reviewing Tevimbra as a first-line treatment for unresectable, recurrent, locally advanced or metastatic ESCC, with a decision expected in July. The product is also being reviewed as a treatment for locally advanced, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, with the agency expected to issue a decision on that application in December.
EU regulators approved tislelizumab in 2023 for the treatment of advanced or metastatic ESCC after chemotherapy. An advisory panel of the European Medicines Agency issued a positive recommendation in February for the drug to be approved for the treatment of non-small cell lung cancer.
In September, BeiGene and Novartis (NVS) announced they had terminated their collaboration agreement for tislelizumab, citing changes in the PD-L1 inhibitor market. As part of the termination, BeiGene was to reassume all development and commercialization rights to the product.