U.S. FDA Approves PADCEV® plus Keytruda® for Certain Patients with Bladder Cancer
Pfizer, Inc. (PFE)
Last pfizer, inc. earnings: 4/28 06:45 am
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Source: Business Wire
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 cancerApproval 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 aloneRepresents the first and only ADC and PD-1 inhibitor regimen for this patient population and a potential new standard of care NEW YORK & TOKYO--(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 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
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PFE
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- 11/20/25 - Form 424B5
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