Health

U.S. FDA Approves PADCEV® plus Keytruda® for Certain Patients with Bladder Cancer

NEW YORK & TOKYO, November 21, 2025--Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate (ADC), in combination with the PD-1 inhibitor Keytruda® (pembrolizumab) or Keytruda QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), as neoadjuvant treatment and then continued after cystectomy

articleAstellas Pharma Inc.November 21, 202526/company/astellas-pharma-inc/news/us-fda-approves-padcevr-plus-keytrudar-for-certain-patients-with-bladder-cancer-1
U.S. FDA Approves PADCEV® plus Keytruda® for Certain Patients with Bladder Cancer

About this update from Astellas Pharma Inc.

[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":212,"url":"https://media.zenfs.com/en/business-wire.com/097b44bf9ed164bc0a32d896c9d679e8"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/wLu1bBVTE0BYiCpzEWzSiw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTQyNDtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/097b44bf9ed164bc0a32d896c9d679e8","width":480,"height":212}},"lazy":false},{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":1024,"height":512,"url":"https://media.zenfs.com/en/business-wire.com/69465107ccd7b9bbadc5173beb006d33"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/k5ibRferEgH9dySjhHH_7w--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTQ4MDtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/69465107ccd7b9bbadc5173beb006d33","width":960,"height":480},"lightbox":{"url":"https://s.yimg.com/ny/api/res/1.2/pCi02XyaSJVMc7kxf4MPXg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTIwNDg7aD0xMDI0O2NmPXdlYnA-/https://media.zenfs.com/en/business-wire.com/69465107ccd7b9bbadc5173beb006d33","width":1024,"height":512}}},{"type":"list","items":[{"val":[{"type":"text","content":"PADCEV plus Keytruda is the first and only approved perioperative treatment regimen that can significantly improve survival over current standard of care (surgery alone) in cisplatin-ineligible patients with muscle-invasive bladder cancer","length":238,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Approval is based on unprecedented data from the pivotal Phase 3 EV-303 trial showing a 60% reduction in the risk of disease recurrence, progression or death and a 50% reduction in the risk of death compared to surgery alone","length":224,"tagName":"p","attribs":{}}]},{"val":[{"type":"text","content":"Represents the first and only ADC and PD-1 inhibitor regimen for this patient population and a potential new standard of care","length":125,"tagName":"p","attribs":{}}]}],"tagName":"ul","bulletedList":true,"length":587,"olType":false},{"type":"text","content":"NEW YORK & TOKYO, November 21, 2025--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug A...

More updates from Astellas Pharma Inc.

bladder cancerKeytrudaadverse reactionsbladder canceradjuvant treatmentpembrolizumabcombinationPADCEVMIBC