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New Indication Alert: FDA Approves Keytruda® (pembrolizumab) Plus Padcev® for Urothelial Cancer Indication

Dec 15, 2023

Merck announced that the FDA has approved Keytruda® in combination with Pfizer (previously Seagen)/Astellas’ Padcev® (enfortumab vedotin-ejfv) an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma.

This approval comes considerably earlier than expected.  Merck announced only in November 2023 that the FDA had accepted (for priority review) its new supplemental Biologics License Application (sBLA) seeking this approval.  At that time the FDA had set a target action date of 9 May 2024.