Seagen, Astellas and Merck announce FDA grants priority review to Padcev BLA

Astellas Pharma (ALPMY) and Seagen (SGEN) announced that on November 30, the FDA accepted for priority review a supplemental Biologics License Application – sBLA – for Padcev with Merck’s (MRK) Keytruda as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer, a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body. The FDA has set a target action date of May 9, 2024. The FDA is reviewing the application under its Real-Time Oncology Review program. approved, this combination would be the first treatment option for cisplatin eligible and ineligible patients. The sBLA for first-line use of the combination is based on results from the Phase 3 EV-302 clinical trial, which found that the combination improved overall survival and progression-free survival with statistically significant and clinically meaningful results in patients with previously untreated la/mUC compared to platinum-containing chemotherapy. Safety results were consistent with those previously reported with this combination, and no new safety issues were identified. The EV-302 trial, which is intended to serve as the confirmatory trial for the U.S. accelerated approval and as the basis for global regulatory submissions, is also intended to expand the indication into the cisplatin-eligible patient population.