24 September 2024 - Approval based on the EV-302 trial where the treatment combination nearly doubled median overall survival and significantly extended progression free survival compared to platinum-containing chemotherapy, the current standard of care for first-line treatment of radically unresectable urothelial carcinoma.
Astellas Pharma today announced that Japan's MHLW has approved Padcev (enfortumab vedotin) with MSD's Keytruda (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with radically unresectable urothelial carcinoma.