FDA Grants Priority Review to Padcev-Keytruda Combo After EV-304 Trial
Pfizer and Astellas received FDA priority review for their sBLA of perioperative Padcev combined with Keytruda in all muscle-invasive bladder cancer patients, targeting approval by August 17, 2026. Phase III EV-304 showed a 47% reduction in recurrence risk, a 35% mortality reduction, and a 55.8% pCR rate versus 32.5%.
1. FDA Priority Review
Pfizer and Astellas secured FDA acceptance of their supplemental biologics licence application for perioperative Padcev plus pembrolizumab in muscle-invasive bladder cancer patients, regardless of cisplatin eligibility. The FDA has set an August 17, 2026 target action date under priority review, reflecting the therapy’s potential as a significant treatment advance.
2. Phase III EV-304 Trial Data
The EV-304 trial evaluated perioperative enfortumab vedotin and pembrolizumab versus neoadjuvant gemcitabine-cisplatin chemotherapy followed by surgery. Results showed a 47% decrease in risk of recurrence, progression or death, a 35% mortality reduction, and a pathological complete response rate of 55.8% versus 32.5%, with no new safety concerns.
3. Commercial and Clinical Implications
If approved, the expanded indication could broaden Padcev’s market beyond cisplatin-ineligible patients, offering a new standard of care and potential revenue growth. Global regulatory discussions are underway and positive trial outcomes may support wider adoption in perioperative settings.