Posted by Michael Wonder on 28 Mar 2024
China's National Medical Products Administration accepts Astellas and Pfizer's supplemental biologics license application for enfortumab vedotin with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
28 March 2024 - Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival vs platinum-containing chemotherapy.
Astellas today announced that on March 27, 2024 the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the supplemental Biologics License Application (sBLA) for enfortumab vedotin with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer.
