Perioperative Option Approved in Canada for Patients with Muscle-Invasive Bladder Cancer Unable to Receive Cisplatin-Based Therapy

Health Canada Decision Supported by Evidence from EV-303 Study

KIRKLAND, QC, June 29, 2026 /CNW/ - Pfizer Canada ULC announced today that Health Canada has, under priority review and Project Orbis initiative, approved PADCEV (enfortumab vedotin for injection), in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. Project Orbis is an initiative of the FDA which provides a framework for coordinating submission and review of oncology products among international health authorities, including Health Canada. This approval is based on data from the EV-303 clinical trial, which evaluated this combination as a treatment option before and after surgery for patients who are ineligible for cisplatin-containing chemotherapy.

"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, Bladder Cancer Canada.

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. PADCEV is also indicated for the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer who have previously received platinum‑containing chemotherapy, and a PD‑1 or PD‑L1 inhibitor. As with any therapy, treatment selection should be based on the approved Canadian Product Monographs and the individual patient's clinical circumstances.

About Muscle-Invasive Bladder Cancer (MIBC)

Bladder cancer is the fifth most commonly diagnosed cancer in Canada. In 2025, approximately 13,000 Canadians were diagnosed with bladder cancer, and approximately a quarter of these cases involved muscle-invasive disease.¹

MIBC occurs when cancer grows into the muscle layer of the bladder wall, making it more aggressive than non-muscle-invasive disease.² The standard treatment for patients with MIBC is neoadjuvant cisplatin-based chemotherapy followed by surgery, which has been shown to prolong survival. However, up to half of patients who are diagnosed with MIBC are not eligible to receive cisplatin and face limited treatment options, typically undergoing surgery without any systemic treatment.³

"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."

About EV-303 (KEYNOTE-905)

The Health Canada approval was supported by data from EV-303, a Phase 3 randomized, open-label trial that compared perioperative (neoadjuvant and adjuvant) PADCEV plus KEYTRUDA and surgery in cisplatin-ineligible patients with MIBC.

"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."

About Pfizer Canada Inc.

Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. At Pfizer, we apply science and our global resources to bring therapies to people that help extend and improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products. Every day, Pfizer colleagues work to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on LinkedIn, Facebook, Instagram or YouTube.

About the Pfizer, Astellas and Merck Collaboration

Seagen and Astellas entered a clinical collaboration agreement with Merck to evaluate the combination of Seagen's and Astellas' PADCEV® (enfortumab vedotin) and Merck's KEYTRUDA® (pembrolizumab) in patients with bladder cancer across various disease stages, ranging from perioperative to previously untreated metastatic urothelial cancer. As previously announced, Pfizer Inc. successfully completed its acquisition of Seagen Inc. on December 14, 2023.  KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

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¹ Ozgun G, Alexander A, Arbour G, Kollmannsberger C, Eigl BJ, Parimi S. Bladder Preservation in Muscle-Invasive Bladder Cancer: A Population-Based Analysis from British Columbia. Curr Oncol. 2025 Dec 11;32(12):699. doi: 10.3390/curroncol32120699. PMID: 41440227; PMCID: PMC12732020. https://pmc.ncbi.nlm.nih.gov/articles/PMC12732020/, Accessed April 30, 2026.

² Funt SA, Rosenberg JE. Systemic, perioperative management of muscle-invasive bladder cancer and future horizons. Nat Rev Clin Oncol. 2017 Apr;14(4):221-234. doi: 10.1038/nrclinonc.2016.188. Epub 2016 Nov 22. PMID: 27874062; PMCID: PMC6054138.

³ Bladder Cancer Canada, Muscle Invasive Bladder Cancer, https://bladdercancercanada.org/en/bladder-cancer/types-of-bladder-cancer/muscle-invasive-bladder-cancer/, Accessed April 30, 2026.

SOURCE Pfizer Canada Inc.

For more information: Pfizer Canada Communications, [email protected]