Astellas announced that the China National Medical Products Administration (NMPA) accepted its supplemental Biologics License Application (sBLA) for enfortumab vedotin and Keytruda® (pembrolizumab) combination therapy for adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). If approved, enfortumab vedotin with Keytruda® (pembrolizumab) would become the first combination treatment to offer an alternative to platinum-containing chemotherapy in China.
The European Medicines Agency (EMA) validated a Type II variation application for the same indication earlier this year.