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FDA Grants Priority Review for Keytruda® (pembrolizumab) Plus Padcev® for Urothelial Cancer Indication

Nov 30, 2023

Merck announced that the FDA has accepted for priority review its new supplemental Biologics License Application (sBLA) seeking approval for Keytruda® in combination with Seagen/Astellas’ Padcev® (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma.  The FDA has set a target action date of 9 May 2024.