The U.S. Food and Drug Administration approved the combination of Pfizer’s PADCEV® (enfortumab vedotin‑ejfv) and Merck’s Keytruda® (pembrolizumab) for the peri‑operative treatment of cisplatin‑ineligible patients with muscle‑invasive bladder cancer on November 21, 2025. The approval expands PADCEV’s use to neoadjuvant therapy before cystectomy and as a post‑surgery option for patients who cannot undergo surgery, marking the first time an antibody‑drug conjugate (ADC) has been combined with a PD‑1 inhibitor for this setting.
The decision was based on the Phase 3 EV‑303 (KEYNOTE‑905) trial, which demonstrated a 60 % reduction in the risk of disease recurrence, progression, or death and a 50 % reduction in the risk of death compared with surgery alone. The trial’s robust event‑free and overall survival benefits, coupled with a manageable safety profile, satisfied the FDA’s stringent criteria for peri‑operative use. The approval also carries a boxed warning for serious skin reactions, including Stevens‑Johnson syndrome and toxic epidermal necrolysis, underscoring the need for vigilant monitoring.
For Pfizer, the approval strengthens its oncology pipeline and creates a new revenue stream in a high‑margin therapeutic area. PADCEV is co‑developed and commercialized with Astellas Pharma, and the company’s acquisition of Seagen in 2023 positioned it to bring the ADC to market. The combination’s approval is expected to accelerate market entry, broaden the patient base, and position Pfizer to compete more effectively against other checkpoint‑inhibitor combinations in the bladder‑cancer market. The approval also signals a potential new standard of care for cisplatin‑ineligible patients, addressing a critical unmet need.
The regulatory clearance is a significant milestone for the oncology segment, as it expands the commercial indication for PADCEV and enhances Pfizer’s competitive positioning. By offering a peri‑operative therapy that improves event‑free and overall survival, Pfizer can capture a larger share of the bladder‑cancer market, which is projected to grow driven by rising incidence and an aging population. The approval also highlights the strategic value of the ADC platform and the partnership with Astellas, reinforcing Pfizer’s broader oncology strategy.
The FDA’s decision reflects confidence in the clinical data and the safety profile of the combination. It also underscores the importance of addressing the unmet needs of patients who cannot tolerate cisplatin‑based chemotherapy, a group that historically has limited treatment options and high recurrence rates. The approval is expected to drive future sales growth and reinforce Pfizer’s position as a leader in innovative oncology therapies.
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