FDA Grants Priority Review to PADCEV and Keytruda for MIBC with 47% EFS Benefit
FDA accepts sBLA for perioperative PADCEV plus Keytruda in MIBC regardless of cisplatin eligibility, granting Priority Review with an August 17, 2026 review date. Phase 3 EV-304 data show a 47% risk reduction in recurrence, a 35% lower mortality risk and a 55.8% pCR rate versus 32.5% with cisplatin chemotherapy.
1. FDA Grants Priority Review
The FDA has accepted a supplemental biologics license application for perioperative PADCEV in combination with Keytruda for muscle-invasive bladder cancer patients regardless of cisplatin eligibility. The agency has set an August 17, 2026 target action date for its Priority Review designation under the Prescription Drug User Fee Act.
2. EV-304 Trial Outcomes
In the randomized Phase 3 EV-304 trial, perioperative enfortumab vedotin plus pembrolizumab delivered a 47% reduction in the risk of recurrence, progression or death and a 35% decrease in overall mortality risk compared with standard cisplatin-based chemotherapy. The regimen also achieved a 55.8% pathological complete response rate at surgery versus 32.5% in the chemotherapy arm, with no new safety signals observed.
3. Potential Commercial Impact
If approved, this regimen would become the first perioperative treatment for all MIBC patients and could establish a new standard of care. The expanded label is expected to broaden the addressable patient population and drive higher peak sales for the PADCEV and Keytruda combination.