TOKYO (dpa-AFX) - Astellas Pharma Inc. (ALPMY) and Pfizer Inc. (PFE) on Monday said the U.S. Food and Drug Administration has granted Priority Review for a supplemental Biologics License Application for perioperative PADCEV in combination with Keytruda as a treatment for patients with Muscle-Invasive Bladder Cancer (MIBC).
The regimen was approved by the FDA in November 2025 for perioperative use in cisplatin-ineligible patients with MIBC. The current filing seeks to expand the indication to include patients regardless of cisplatin eligibility.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 17, 2026.
The submission is based on data from the Phase III EV-304 study evaluating perioperative PADCEV in combination with Keytruda in patients eligible for cisplatin-containing chemotherapy. The study showed a 47% reduction in the risk of tumor recurrence, progression or death and a 35% reduction in the risk of death compared with standard neoadjuvant gemcitabine and cisplatin chemotherapy.
The combination also demonstrated a pathological complete response rate of 55.8%, compared with 32.5% in the chemotherapy arm at the time of surgery.
Astellas Pharma noted that Seagen and Astellas, which originally developed PADCEV, had partnered with Merck to evaluate the combination of PADCEV with Merck's Keytruda in patients with MIBC eligible for cisplatin-based chemotherapy. Pfizer had completed its acquisition of Seagen in December 2023.
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