KIRKLAND – Pfizer Canada ULC announced that Health Canada has approved PADCEV® (enfortumab vedotin) an antibody-drug conjugate (ADC) in combination with pembrolizumab, a PD-1 inhibitor, for the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer (la/mUC) with no prior systemic therapy for mUC.
The approval was made under the Health Canada Priority Review process, after having met the criteria of substantial evidence of clinical effectiveness providing an improved benefit/risk profile over existing therapies. The approval is based in part on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). Findings from EV-302 were presented at the European Society for Medical Oncology (ESMO) 2023 Congress.
Bladder cancer affects approximately 12,300 Canadians each year and claims the lives of approximately 2,600 Canadians every year.[i] Urothelial cancer, or bladder cancer, begins in the urothelial cells, which line the urethra, bladder, ureters, and renal pelvis.[ii] The advanced stages of urothelial cancer are often referred to as locally advanced or metastatic. Although some locally advanced or metastatic bladder cancers will stop growing, shrink, or even disappear in response to current treatment options, the cancer almost always returns and grows aggressively, shortening life expectancy.[iii]
Srikala Sridhar, MD, Head of the Genitourinary Medical Oncologists of Canada, Professor and Medical Oncologist at the Princess Margaret Cancer Centre, in Toronto
“Metastatic urothelial cancer is an aggressive disease with limited treatment options and a poor prognosis. This approval represents an important step forward in the treatment of advanced bladder cancer. This combination of an antibody drug conjugate and immunotherapy in the first-line setting offers new hope for our patients and their families.”
Michelle Colero, Executive Director, Bladder Cancer Canada
“We are thrilled that Health Canada has approved a new treatment option for advanced bladder cancer, and we are excited about the hope it will provide to members of the bladder cancer patient community. Despite recent advances in the treatment of advanced bladder cancer, there remains an important need for new therapies for patients.”
Cynthia Di Lullo, Oncology Lead, Pfizer Canada
“Today’s Health Canada’s approval represents an opportunity to help change the treatment of advanced bladder cancer and provides a new option to the thousands of Canadians impacted by this aggressive disease. At Pfizer, we are committed to improving the lives of Canadians and we are proud of our scientific innovations, including targeted therapies, such as PADCEV, that continue to address and support those living with cancer.”