FDA Grants Priority Review for Merck’s KEYTRUDA, KEYTRUDA QLEX with Padcev in MIBC
The U.S. FDA granted priority review for two supplemental applications of KEYTRUDA and KEYTRUDA QLEX in combination with Padcev for cisplatin-eligible muscle-invasive bladder cancer, setting an August 17, 2026 PDUFA action date. Approval would expand perioperative treatment options regardless of cisplatin eligibility.
1. Priority Review Granted
The FDA has granted priority review for two supplemental biologics license applications for KEYTRUDA and KEYTRUDA QLEX, each combined with Padcev, targeting cisplatin-eligible muscle-invasive bladder cancer. The agency set a PDUFA date of August 17, 2026, accelerating evaluation of these perioperative treatment indications.
2. KEYNOTE-B15 Trial Data
The sBLAs rely on data from the Phase 3 KEYNOTE-B15 trial which randomized 808 cisplatin-eligible patients to perioperative KEYTRUDA plus Padcev and surgery versus neoadjuvant gemcitabine/cisplatin plus surgery. The primary endpoint is event-free survival, with secondary endpoints including overall survival and pathologic complete response rate.
3. Potential Commercial Impact
If approved, these indications would extend Merck’s therapies to all perioperative patients with muscle-invasive bladder cancer regardless of cisplatin eligibility. This broadens the existing metastatic urothelial cancer landscape and builds on three Phase 3 trials demonstrating overall survival benefit.