Priority Review to Merck’s Application for KEYTRUDA Plus Padcev in Urothelial Cancer

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC). This application is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which aims to improve the efficiency of the review process of applications to ensure that treatments are available to patients as early as possible. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of May 9, 2024.

https://www.businesswire.com/news/home/20231130062501/en/FDA-Grants-Priority-Review-to-Merck%E2%80%99s-Application-for-KEYTRUDA%C2%AE-pembrolizumab-Plus-Padcev%C2%AE-enfortumab-vedotin-ejfv-for-the-First-Line-Treatment-of-Patients-With-Locally-Advanced-or-Metastatic-Urothelial-Cancer