KIRKLAND, Quebec, Canada, June 29, 2026
Pfizer Canada ULC announced that Health Canada has approved PADCEV® (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) as a perioperative treatment for adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. Granted under Priority Review through Project Orbis, the approval covers the use of the combination as neoadjuvant therapy before radical cystectomy and as adjuvant therapy following surgery. The decision is supported by findings from the Phase 3 EV-303 (KEYNOTE-905) clinical trial, which demonstrated the potential of the combination to provide an evidence-based treatment option for patients with limited therapeutic alternatives before surgery. The approval marks an important expansion of PADCEV’s role in earlier-stage bladder cancer treatment and provides physicians with a new perioperative regimen for patients unable to receive standard cisplatin-based chemotherapy.
EV-303 Trial Supports New Perioperative Treatment Strategy
The approval is based on results from the Phase 3 EV-303 (KEYNOTE-905) study, a randomized, open-label clinical trial evaluating PADCEV plus KEYTRUDA administered before surgery and continued after radical cystectomy in patients with cisplatin-ineligible muscle-invasive bladder cancer. The study investigated whether combining an antibody-drug conjugate with an immune checkpoint inhibitor could improve treatment options for patients who historically had few alternatives beyond surgery alone. According to Dr. Wassim Kassouf, Professor of Urology at the McGill University Health Centre, many patients with MIBC cannot receive cisplatin-based chemotherapy, making the approval a significant advancement that introduces an evidence-based perioperative regimen for clinicians managing this challenging patient population. The regulatory decision reflects growing confidence in innovative combination therapies aimed at improving outcomes in earlier stages of bladder cancer.
Approval Addresses Significant Unmet Need in Canada
Bladder cancer remains the fifth most commonly diagnosed cancer in Canada, with approximately 13,000 new cases reported in 2025, including nearly one-quarter involving muscle-invasive disease. MIBC develops when cancer invades the bladder muscle, making it substantially more aggressive than non-muscle-invasive forms and increasing the risk of disease progression and metastasis. Although cisplatin-based chemotherapy followed by radical cystectomy has long been considered the standard of care, nearly half of patients are unable to receive cisplatin because of underlying health conditions or treatment-related risks. For these individuals, surgery alone has often been the only available option. The newly approved PADCEV plus KEYTRUDA regimen offers a meaningful treatment alternative by providing systemic therapy before and after surgery for patients previously lacking effective perioperative options.
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Pfizer Strengthens Oncology Portfolio Through Regulatory Expansion
The latest approval further expands Pfizer Canada’s oncology portfolio and builds on PADCEV’s previous Canadian approvals for locally advanced and metastatic urothelial cancer. Company officials stated that they will work closely with healthcare professionals to facilitate access to the newly approved treatment for eligible patients across Canada. The approval also highlights the continued impact of Project Orbis, an international regulatory collaboration led by the U.S. FDA that enables coordinated reviews of promising oncology therapies among global health authorities. By extending the use of PADCEV plus KEYTRUDA into the perioperative treatment setting, Pfizer continues to advance innovative therapies designed to improve outcomes for patients with difficult-to-treat bladder cancers while supporting broader access to evidence-based oncology treatments.
Source: Pfizer Canada press release
