Seagen, Astellas and Merck announce FDA acceptance of sBLA in urothelial cancer

Seagen (SGEN), Astellas Pharma (ALPMF) and Merck (MRK) announced the FDA has accepted for Priority Review supplemental Biologics License Applications – sBLAs – for Padcev and Keytruda for use of these two agents in combination for the treatment of patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy. The respective applications are intended to expand both labels for Padcev and Keytruda. The agency set a Prescription Drug User Fee Act goal date for each application of April 21, 2023. The combination therapy was granted Breakthrough Therapy designation by the FDA in February 2020. Seagen, Astellas and Merck are further investigating enfortumab vedotin plus pembrolizumab in the ongoing phase 3 EV-302 study evaluating the clinical benefit for the investigational treatment combination in patients with previously untreated advanced urothelial cancer. The trial is intended to serve as the confirmatory trial for the potential accelerated approval in the U.S. and serve as the basis for global registration.