Astellas, Seagen, and Merck announce priority review for Padcev and Keytruda

Astellas Pharma (ALPMY), Seagen (SGEN) and Merck (MRK) announced the FDA has accepted for priority review supplemental biologics license applications, or 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, or la/mUC, 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, or PDUFA, goal date for each application of April 21, 2023.