15 February 2024 - Priority review designation is based on results from the Phase 3 EV-302 trial, which found enfortumab vedotin plus pembrolizumab significantly extended overall survival and progression free survival compared to platinum-containing chemotherapy.

Astellas Pharma today announced that Japan's Ministry of Health, Labour and Welfare has granted priority review for the company's supplemental new drug application for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer.

Read Astellas press release