Seagen, Astellas announce FDA grants Padcev with Keytruda accelerated approval

Seagen (SGEN) and Astellas Pharma (ALPMY) announced the FDA has granted Padcev with Keytruda accelerated approval in the U.S. as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in the EV-302 confirmatory trial.