FDA accelerated approval covers Padcev plus Keytruda in urothelial carcinoma
The agency's 2023 clearance applies to patients with locally advanced or metastatic urothelial carcinoma who cannot receive cisplatin-based chemotherapy.
On April 3, 2023, the Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev, Astellas Pharma) with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.1
The approval pairs Astellas Pharma's antibody-drug conjugate with Merck's checkpoint inhibitor for this specific patient population, as stated in the FDA's record of the decision. No additional details on trial data, dosing schedules, or further regulatory steps were included in the posted record.
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