Merck has secured a regulatory step forward for its flagship oncology franchise.
This is with the US FDA granting priority review for the pharma giant's KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph) combo for bladder cancer patients.
Both applications evaluate the therapies in combination with Padcev (enfortumab vedotin-ejfv) for patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 17, 2026.
If approved, the move would significantly broaden the use of KEYTRUDA and KEYTRUDA QLEX in combination with Padcev, positioning them as the first perioperative treatment options for MIBC across cisplatin-eligible and ineligible populations. It would also extend their role beyond currently approved use in cisplatin-ineligible patients.
Merck says the filings are backed by data from the Phase 3 KEYNOTE-B15 (EV-304) trial, developed with Pfizer and Astellas and recently presented at the ASCO Genitourinary Cancers Symposium. The companies intend to submit the findings to regulators globally for further potential approvals.
“Results from KEYNOTE-B15 challenge long-held expectations for patients with muscle-invasive bladder cancer,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.
“Even with curative-intent surgery and chemotherapy, patients still experience disease progression or limited survival. These data add to the growing body of evidence demonstrating that KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, have the potential to reshape how we approach treatment for these patients and improve outcomes for people facing this aggressive disease.”
Merck highlighted that the combination has now shown an overall survival benefit across three Phase 3 trials in bladder cancer, including KEYNOTE-B15, KEYNOTE-905, and KEYNOTE-A39. Additional late-stage studies continue to evaluate KEYTRUDA across the full bladder cancer spectrum, from non-muscle-invasive to metastatic disease.
