Posted by Michael Wonder on 31 Jan 2024
Astellas submits supplemental new drug application in Japan for Padcev (enfortumab vedotin) with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
31 January 2024 - Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival versus platinum-containing chemotherapy.
Astellas Pharma today announced the submission of a supplemental new drug application on 31 January to Japan's Ministry of Health, Labour and Welfare 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.
