Astellas Pharma and Pfizer reported that the FDA has accepted for Priority Review a supplemental Biologics License Application (sBLA) for PADCEV (enfortumab vedotin-ejfv) in combination with Keytruda (pembrolizumab) or Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph) as perioperative treatment for patients with muscle-invasive bladder cancer (MIBC). The regimen is already FDA‑approved as a perioperative option for cisplatin‑ineligible patients with MIBC; the current filing seeks to expand the indication to include patients regardless of cisplatin eligibility. Under the Prescription Drug User Fee Act, the FDA has set a target action date of August 17, 2026.
The Priority Review is based on data from the Phase 3 EV‑304 (KEYNOTE‑B15) trial, which evaluated perioperative enfortumab vedotin plus pembrolizumab versus standard neoadjuvant gemcitabine and cisplatin in cisplatin‑eligible patients with MIBC. In EV‑304, the combination reduced the risk of tumor recurrence, progression or death by 47% and reduced the risk of death by 35% compared with the chemotherapy control arm. The regimen also achieved a pathological complete response rate of 55.8% versus 32.5% with gemcitabine and cisplatin at the time of surgery.
According to Astellas and Pfizer, the safety profile of perioperative enfortumab vedotin plus pembrolizumab in EV‑304 was consistent with prior experience with the combination, with no new safety signals observed. The companies plan to discuss the EV‑304 data with additional health authorities to support potential regulatory submissions outside the United States.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!