On Friday, the U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s (NYSE:PFE) and Astellas Pharma Inc.’s (OTC:ALPMF) (OTC:ALPMY) PADCEV (enfortumab vedotin-ejfv) combo regimen for bladder cancer.
The approval covers PADCEV in combination with Keytruda (pembrolizumab) or Keytruda QLEX (pembrolizumab and berahyaluronidase alfa-pmph) as neoadjuvant and adjuvant treatment for adults with muscle-invasive bladder cancer (MIBC), regardless of their eligibility for cisplatin.
The decision makes the combination the first platinum-free regimen approved for this patient population.
Phase 3 Trial Supported Expanded Approval
The FDA’s expanded approval was supported by findings from the Phase 3 EV-304 trial, also known as KEYNOTE-B15, which were presented at the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium.
The latest approval builds on the agency’s November 2025 decision, which cleared the combination as neoadjuvant and adjuvant therapy for cisplatin-ineligible adults with MIBC based on results from the Phase 3 EV-303 trial, also known as KEYNOTE-905.
Trial Compared Combination Against Standard Chemotherapy
In the EV-304 study, patients were randomly assigned to receive surgery with neoadjuvant and adjuvant PADCEV plus pembrolizumab or surgery with neoadjuvant chemotherapy using gemcitabine and cisplatin.
Patients receiving the PADCEV combination were treated with a planned total of nine cycles of PADCEV and 17 cycles of pembrolizumab administered before and after surgery.
Study Showed Improvements Across Key Endpoints
The combination reduced the risk of tumor recurrence, disease progression, or death by 47% compared with standard neoadjuvant gemcitabine and cisplatin chemotherapy, corresponding to a hazard ratio of 0.53.
At the two-year mark, an estimated 79.4% of patients treated with PADCEV plus pembrolizumab remained event-free, compared with 66.2% of patients who received standard chemotherapy.
The regimen also lowered the risk of death by 35% versus neoadjuvant chemotherapy, with a hazard ratio of 0.65.
In addition, the pathological complete response rate at the time of surgery was 55.8% for patients treated with PADCEV plus pembrolizumab, compared with 32.5% in those who received chemotherapy.
PFE Stock Price Activity: Pfizer shares were up 0.02% at $24.25 at the time of publication on Friday, according to Benzinga Pro data.
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