FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer
Merck, operating as MSD internationally, reported that the U.S. Food and Drug Administration (FDA) has prioritized the review of a supplementary Biologics License Application (sBLA). This application focuses on obtaining approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in conjunction with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate. The intended use is for treating adult patients dealing with locally advanced or metastatic urothelial carcinoma (la/mUC). The FDA is expediting the r...