Pfizer (NYSE:PFE) and Astellas announced today that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a supplemental Biologics License Application (sBLA) for the perioperative use of Padcev (enfortumab vedotin-ejfv) in combination with Keytruda (pembrolizumab).
The proposed indication aims to treat patients with muscle-invasive bladder cancer (MIBC) regardless of their eligibility for cisplatin-based chemotherapy.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 17, 2026.
If approved, this regimen would mark a significant shift in the treatment paradigm for MIBC, offering a potent immunotherapy and antibody-drug conjugate (ADC) combination to a broader patient population prior to and following surgery.
The submission is supported by high-level results from the Phase 3 EV-304 (also known as KEYNOTE-B15) trial.
The data demonstrated that the Padcev-Keytruda combination achieved a 47% reduction in the risk of disease recurrence or progression and a 35% reduction in the risk of death compared to standard-of-care chemotherapy.
Furthermore, the combination showed a pathologic complete response (pCR) rate of 55.8%, significantly higher than the 32.5% observed in the chemotherapy arm.
Padcev and Keytruda are already established as a standard for locally advanced or metastatic urothelial cancer.
This latest regulatory milestone seeks to move the combination into the earlier "perioperative" setting—treating patients both before surgery (neoadjuvant) and after surgery (adjuvant) to maximize the potential for long-term remission.