Astellas: PADCEV, KEYTRUDA Granted Priority Review In Treatment Of Metastatic Urothelial Cancer

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY), Seagen Inc. (SGEN) and Merck (MRK) announced the FDA has accepted for Priority Review supplemental Biologics License Applications 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 applications are intended to expand both labels for PADCEV and KEYTRUDA. The FDA set a PDUFA goal date for each application of April 21, 2023.

Astellas, Seagen and Merck are further investigating enfortumab vedotin plus pembrolizumab in the phase 3 EV-302 study, evaluating the clinical benefit for the investigational combination in patients with previously untreated advanced urothelial cancer.

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