Posted by Michael Wonder on 21 Sep 2023
BeiGene announces positive regulatory updates in Europe and the US after recently regaining global rights for Tevimbra
19 September 2023 - European Commission approves Tevimbra for previously treated advanced or metastatic oesophageal squamous cell carcinoma.
BeiGene today announced that the European Commission has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy.
Additionally, the US FDA accepted for review a biologics license application for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic oesophageal squamous cell carcinoma.
