Posted by Michael Wonder on 02 Dec 2023
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) for the first-line treatment of patients with locally advanced or metastatic urothelial cancer
30 November 2023 - Acceptance based on results from the Phase 3 KEYNOTE-A39 trial, which showed a statistically significant and clinically meaningful improvement in overall survival and progression-free survival versus chemotherapy in these patients.
Merck today announced that the US FDA has accepted for priority review a new supplemental biologics license application 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.
