RHHBY - FDA Approves BeiGene's First Drug Candidate Produced Through Its Immuno-Oncology Program For Esophageal Cancer | Benzinga
On Thursday, the FDA approved BeiGene Ltd’s (NASDAQ:BGNE) approved Tevimbra (tislelizumab-jsgr) as monotherapy for adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
Tevimbra will be available in the U.S. in the second half of 2024. The approval represents the first indication in the U.S. for Tevimbra.
In September 2023, BeiGene said it would regain rights to develop, manufacture, and commercialize Tevimbra (tislelizumab), its cancer drug, from Novartis AG (NYSE:NVS). Under the agreement signed in 2021, the companies were jointly developing ...