In a significant development in the fight against urothelial cancer, Astellas Pharma Inc. announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has awarded priority review status to its Supplemental New Drug Application (sNDA) for PADCEV (enfortumab vedotin) in combination with KEYTRUDA (pembrolizumab) as a first-line treatment for adults with previously untreated locally advanced […]
A groundbreaking development in bladder cancer treatment is on the horizon as Astellas Pharma Inc. and Pfizer Inc. await the European Medicines Agency’s (EMA) review of their recent application. This significant step involves a Type II variation application for PADCEV (enfortumab vedotin) combined with KEYTRUDA (pembrolizumab), targeting first-line treatment of adult patients with previously untreated […]
Seagen Inc. and Astellas Pharma Inc. have announced encouraging results from the Phase 3 EV-302 clinical trial, presenting PADCEV in combination with KEYTRUDA versus chemotherapy. This potent combination significantly improved overall survival (OS) and progression-free survival (PFS) for patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). Highlighted Findings from the EV-302 Study […]