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PADCEV™ (enfortumab vedotin-ejfv) Plus KEYTRUDA® (pembrolizumab) sBLA Granted FDA Priority Review for Treatment of Certain Patients with Muscle-Invasive Bladder Cancer
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV™ (enfortumab vedotin-ejfv) in combination with KEYTRUDA® (pembrolizumab) as a neoadjuvant treatment (before surgery) and then continued after radical cystectomy as adjuvant treatment (after surgery) for patients with muscle-invasive bladder cancer (MIBC) who are i
About this update from Astellas Pharma Inc.
[{"type":"text","content":"Results from the pivotal EV-303 trial demonstrated that, when used before and after surgery, the combination reduced the risk of recurrence, progression or death by 60% and the risk of death by 50% in cisplatin-ineligible patients with muscle-invasive bladder cancer","length":266,"tagName":"p","attribs":{}},{"type":"text","content":"If approved, PADCEV plus KEYTRUDA could fundamentally change the treatment approach for patients with this disease","length":114,"tagName":"p","attribs":{}},{"type":"text","content":"TOKYO, Oct. 22, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV™ (enfortumab vedotin-ejfv) in combination with KEYTRUDA® (pembrolizumab) as a neoadjuvant treatment (before surgery) and then continued after radical cystectomy as adjuvant treatment (after surgery) for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.","length":605,"tagName":"p"},{"type":"image","alt":"Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.(PRNewsFoto/Astellas Pharma Inc.) (PRNewsfoto/Astellas Pharma Inc.)","displaySize":"","headline":null,"caption":"Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.(PRNewsFoto/Astellas Pharma Inc.) (PRNewsfoto/Astellas Pharma Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":110,"url":"https://media.zenfs.com/en/prnewswire.com/2ea847d4f0afcbab05cc0666e5cfd53b"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/gt2H1Ajgjzgw_owZJZe3uA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTE5NDtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/2ea847d4f0afcbab05cc0666e5cfd53b","width":400,"height":110}},"href":"https://mma.prnewswire.com/media/458529/Astellas_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of April 7, 2026.","length":109,"tagName":"p"},{"type":"text","content":"The sBLA submission was based on results from the pivotal Phase 3 EV-303 clinical trial (also known as K...