RAHWAY, N.J. — The U.S. Food and Drug Administration has granted priority review to two applications from Merck seeking expanded use of its cancer therapy KEYTRUDA in combination with Padcev for patients with muscle-invasive bladder cancer eligible for cisplatin-based chemotherapy.
The agency set a target decision date of Aug. 17, 2026, under the Prescription Drug User Fee Act.
The applications cover KEYTRUDA (pembrolizumab) and a newer formulation, KEYTRUDA QLEX (pembrolizumab and berahyaluronidase alfa-pmph), each used in combination with Padcev (enfortumab vedotin-ejfv). If approved, the regimens could become the first perioperative treatment options for patients with muscle-invasive bladder cancer regardless of cisplatin eligibility.
The filings are supported by results from the Phase 3 KEYNOTE-B15 trial, which showed that the combination of KEYTRUDA and Padcev significantly improved both event-free survival and overall survival compared with standard treatment.
“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.”
The combination therapy is already approved in multiple regions, including the United States, for patients with advanced or metastatic urothelial cancer, as well as for certain patients with muscle-invasive bladder cancer who are not eligible for cisplatin-based chemotherapy.
Merck said the latest applications aim to expand use of the regimen to a broader patient population and earlier stage of disease.
The KEYNOTE-B15 study was conducted in collaboration with Pfizer and Astellas, with results previously presented at a major oncology conference. The companies plan to submit the data to regulatory authorities globally.
The combination of KEYTRUDA and Padcev has now demonstrated an overall survival benefit across three Phase 3 trials in bladder cancer. Additional late-stage studies are ongoing to evaluate KEYTRUDA-based regimens across different stages of the disease, including non-muscle-invasive, muscle-invasive, and metastatic bladder cancer.
KEYTRUDA continues to be one of the most widely studied immunotherapies, with multiple trials exploring its use in combination with other treatments and across a range of cancer types.
