Merck & Co. announced that the U.S. Food and Drug Administration has granted priority review for two supplemental Biologics License Applications (sBLAs) covering KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab with berahyaluronidase alfa‑pmph) in combination with Padcev® (enfortumab vedotin‑ejfv) for patients with muscle‑invasive bladder cancer who are eligible for cisplatin‑based chemotherapy. The FDA’s target action date for the review is August 17, 2026, a shortened timeline that reflects the agency’s view of the combination’s potential clinical benefit.
The priority‑review designation shortens the FDA’s review period from the standard 10 months, signaling that the agency expects the Keytruda‑Padcev combination to offer a significant therapeutic advance. If approved, the indication would extend Merck’s bladder‑cancer portfolio beyond its current approvals for locally advanced or metastatic urothelial cancer and for cisplatin‑ineligible MIBC patients, potentially establishing the combination as the first perioperative treatment that can be used regardless of cisplatin eligibility.
The sBLAs are based on the Phase III KEYNOTE‑B15 trial, conducted in partnership with Pfizer and Astellas. The trial demonstrated that the Keytruda‑Padcev combination produced statistically significant improvements in event‑free survival and overall survival compared with standard chemotherapy in cisplatin‑eligible MIBC patients, providing the clinical evidence that underpins the regulatory filing.
Strategically, the priority review expands Merck’s bladder‑cancer pipeline and positions the company to capture a larger share of the perioperative market ahead of the Keytruda patent cliff expected around 2028. By adding a cisplatin‑eligible indication, Merck diversifies its oncology revenue streams and strengthens its competitive stance against other immuno‑oncology players, reinforcing investor confidence in the company’s growth trajectory.
Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, said, “Results from KEYNOTE‑B15 challenge long‑held expectations for patients with muscle‑invasive bladder cancer. 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.”
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