Health
FDA Grants Priority Review for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each with Padcev® (enfortumab vedotin-ejfv), for Cisplatin-Eligible Patients with Muscle-Invasive Bladder Cancer
RAHWAY, N.J., April 20, 2026--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapy, each in combination with Padcev® (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cance
About this update from Merck & Company, Inc.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":217,"url":"https://media.zenfs.com/en/business-wire.com/219f170ccf61652a9835293daccc1c68"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/uo1aQi14bfam3AmMYewOPQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTQzNA--/https://media.zenfs.com/en/business-wire.com/219f170ccf61652a9835293daccc1c68","width":480,"height":217}},"lazy":false},{"type":"text","content":"Applications are supported by the Phase 3 KEYNOTE-B15 results, which showed that KEYTRUDA plus Padcev demonstrated a statistically significant and clinically meaningful improvement in event-free survival and overall survival in study participants","length":246,"tagName":"p","attribs":{}},{"type":"text","content":"If approved, these regimens would be the first and only perioperative treatments for patients with MIBC regardless of cisplatin eligibility, marking potential new standards of care","length":180,"tagName":"p","attribs":{}},{"type":"text","content":"RAHWAY, N.J., April 20, 2026--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapy, each in combination with Padcev® (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date of August 17, 2026.","length":673,"tagName":"p"},{"type":"text","content":"If approved, these indications would expand the use of KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, as the first perioperative treatments for patients with MIBC regardless of cisplatin eligibility and build on the previously approved indications of the combination for the treatment of patients with MIBC who are ineligible for cisplatin-based chemotherapy.","length":373,"tagName":"p"},{"type":"text","content":""Results from KEYNOTE-B15 challenge long-held expectations for patients with muscle-invasive bladder cancer," said Dr. Marjorie Green, senio...