Pfizer Canada ULC announced that Health Canada has approved PADCEV (enfortumab vedotin for injection) in combination with pembrolizumab as a perioperative treatment for adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. The approval was granted under priority review and the Project Orbis initiative.
Approval based on EV-303 clinical trial
The decision is supported by data from the EV-303 Phase 3 randomized, open-label trial, which evaluated the combination as neoadjuvant treatment before radical cystectomy and continued as adjuvant therapy after surgery. Project Orbis, led by the U.S. FDA, coordinates submission and review of oncology products among international health authorities, including Health Canada.
“This approval is meaningful for Canadians who cannot receive cisplatin-based treatment, as it adds a new therapy option for patients and families facing a challenging diagnosis,” said Michelle Colero, Executive Director of Bladder Cancer Canada.
Impact on muscle-invasive bladder cancer care
Bladder cancer is the fifth most commonly diagnosed cancer in Canada. In 2025, approximately 13,000 Canadians were diagnosed with bladder cancer, and about a quarter of these cases involved muscle-invasive disease. MIBC occurs when cancer grows into the muscle layer of the bladder wall, making it more aggressive than non-muscle-invasive disease.
The standard treatment for MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery, which has been shown to prolong survival. However, up to half of patients diagnosed with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery without any systemic treatment.
New evidence-based regimen for cisplatin-ineligible patients
“Historically, patients who cannot receive cisplatin have had few alternatives prior to surgery,” said Dr. Wassim Kassouf, Professor of Urology at McGill University Health Centre. “This approval provides clinicians with new evidence-based regimen in this setting.”
PADCEV was previously approved in Canada in 2024 for the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer (la/mUC) with no prior systemic therapy for mUC. It is also indicated for patients who have previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor. Treatment selection should be based on the approved Canadian Product Monographs and individual patient clinical circumstances.
Pfizer Canada commitment to innovation
“Pfizer Canada is committed to supporting innovation for serious cancers like muscle-invasive bladder cancer,” said Cynthia Di Lullo, Oncology Business Unit Lead at Pfizer Canada. “We will work closely with the healthcare community to help integrate this new treatment option for eligible patients.”
