The U.S. Food and Drug Administration has granted Priority Review to a supplemental Biologics License Application submitted by Pfizer Inc. and Astellas Pharma Inc. for the use of Padcev in combination with Merck’s Keytruda. The application aims to expand the indication for this combination therapy to include patients with muscle-invasive bladder cancer who are undergoing surgery. This regulatory milestone, announced on April 20, 2026, accelerates the review timeline for a treatment regimen that has already established a significant footprint in the advanced or metastatic stages of the disease.
The FDA’s decision to grant Priority Review is supported by results from the Phase 3 EV-304 clinical trial, which is also designated as KEYNOTE-B15. This global, open-label, randomized study compared the efficacy and safety of the enfortumab vedotin and pembrolizumab combination against the standard-of-care cisplatin-based chemotherapy in the neoadjuvant setting. The trial specifically enrolled patients with muscle-invasive bladder cancer who were candidates for radical cystectomy and pelvic lymph node dissection.
According to the clinical data presented in the filing, the combination therapy met its primary endpoints, demonstrating significant improvements in pathological complete response and event-free survival compared to traditional chemotherapy. The safety profile of the combination remained consistent with previous studies, with no new safety signals identified in the perioperative setting. Pfizer and Astellas noted that the application seeks approval for patients regardless of their eligibility for cisplatin, a chemotherapy agent that many bladder cancer patients cannot tolerate due to renal impairment or other comorbidities.
Dr. Chris Boshoff, Chief Oncology Officer at Pfizer, stated that the Priority Review designation underscores the urgent need for new treatment options in the muscle-invasive stage of bladder cancer. He noted that approximately 25 percent of patients diagnosed with urothelial cancer present with muscle-invasive disease, which carries a high risk of recurrence even after surgical intervention. Ahsan Arozullah, Senior Vice President and Head of Oncology Development at Astellas, added that the goal is to provide a highly effective, cisplatin-free option that can be administered before surgery to improve long-term outcomes.
Under the Priority Review designation, the FDA aims to take action on the application within six months, compared to the standard ten-month review period. The agency has set a Prescription Drug User Fee Act goal date for late 2026. If approved, the Padcev and Keytruda combination would become the first antibody-drug conjugate and immunotherapy pairing indicated for the neoadjuvant treatment of muscle-invasive bladder cancer. This follows the 2023 FDA approval of the same combination for the first-line treatment of adult patients with locally advanced or metastatic urothelial cancer.