U.S. FDA Grants Priority Review to sBLA for PADCEV™ + Keytruda® as Perioperative Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility [TheStreet.com]
Pfizer, Inc. (PFE)
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Source: TheStreet.com
PR Newswire TOKYO and NEW YORK, April 20, 2026 Submission based on statistically significant event-free and overall survival data from the Phase 3 EV-304 trial Building on the existing indication in cisplatin-ineligible muscle-invasive bladder cancer (MIBC), if approved, this regimen would be the first and only perioperative treatment for patients with MIBC regardless of cisplatin eligibility, marking a potential new standard of care TOKYO and NEW YORK April 20, 2026 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental Biologics License Application (sBLA) for perioperative (before and after surgery) PADCEV™ (enfortumab vedotin-ejfv), a Nectin-4 directed antibody-drug conjugate, in combination with the PD-1 inhibitor Keytruda ® (pembrolizumab) or Keytruda QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph
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News
- U.S. FDA Grants Priority Review to sBLA for PADCEV™ + Keytruda® as Perioperative Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility [Yahoo! Finance]Yahoo! Finance
- U.S. FDA Grants Priority Review to sBLA for PADCEV™ + Keytruda® as Perioperative Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin EligibilityPR Newswire
- Where Will Pfizer Stock Be in 3 Years? [Globe and Mail, The (Toronto, Canada)]Globe and Mail, The
- Where Will Pfizer Stock Be in 3 Years? [Yahoo! Finance]Yahoo! Finance
- Pfizer (PFE) Valuation Check As COVID Decline And Obesity Pipeline Shift Reshape Its Outlook [Yahoo! Finance]Yahoo! Finance
PFE
Earnings
- 2/3/26 - Beat
PFE
Sec Filings
- 4/17/26 - Form 4
- 4/16/26 - Form 4
- 4/10/26 - Form 3
- PFE's page on the SEC website