Posted by Michael Wonder on 08 Jul 2019
Priority review granted to BeiGene’s supplemental new drug application in China for tislelizumab in urothelial carcinoma
7 July 2019 - BeiGene today announced that the China National Medical Products Administration has granted priority review status to the supplemental new drug application for tislelizumab, an investigational Fc-engineered anti-PD-1 antibody, for patients with previously treated locally-advanced or metastatic urothelial carcinoma.
The application for tislelizumab as a potential treatment for patients with previously treated locally-advanced or metastatic urothelial carcinoma was accepted by the NMPA in May 2019. It is supported by a clinical, non-clinical, and Chemistry, Manufacturing and Controls data package, including the results from a pivotal Phase 2 study of tislelizumab in 113 Chinese and South Korean patients with previously treated PD-L1+ locally-advanced or metastatic urothelial carcinoma.
