Pfizer Inc., PFE, FDA Calendar, PDUFA Date

Company Name	Pfizer Inc. PFE
Drug Name	PADCEV (sBLA)
Event Name	FDA decision on PADCEV plus KEYTRUDA for patients with Muscle-Invasive Bladder Cancer regardless of Cisplatin eligibility
Event Date	08/17/2026
Outcome Date
Outcome	Pending
Drug Status	Priority review PADCEV is jointly developed by Pfizer and Astellas
Rival Drugs
Market Potential
Other Approvals	PADCEV plus KEYTRUDA is already approved as perioperative treatment for adults with Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
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