Regulatory Decision Summary for Imfinzi

Locally advanced or metastatic urothelial carcinoma that has progressed after treatment with a platinum containing regimen is a serious and life-threatening disease that is associated with a poor prognosis. At the time Imfinzi was granted advanced consideration in accordance with the guidance document: Notice of Compliance with Conditions (NOC/c), treatment options were limited to cytotoxic chemotherapy salvage regimens, which are not proven to improve patients quality of life or extend survival. Furthermore, it is recognized that a large proportion of patients in this setting are unable to receive further treatment with cytotoxic chemotherapies leaving best supportive care or clinical trials as the only available options.

Imfinzi, an immunotherapy designed to enhance the immune systems ability to mount an anti-tumour response, was studied as monotherapy in a single-arm study designed to evaluate the safety and anti-tumour effect. Imfinzi was associated with a modest overall response rate (ORR) in a difficult to treat patient population. The observed responses were durable compared to previously reported responses obtained using cytotoxic salvage chemotherapies. The safety profile of Imfinzi has been well characterized in the clinical trial setting and is considered to be consistent with other products that target the PD-1/PD-L1 signaling pathway. Imfinzi is associated with a variety of immune-mediated adverse reactions, but these can be managed with close monitoring and prompt intervention following the guidance outlined in the Canadian product monograph. Given the lack of therapeutic options available to patients within the indication, the evidence provided in support of the efficacy of Imfinzi is considered promising such that the preliminary assessment of benefit-risk can be considered favourable. Confirmation of efficacy in a well-controlled, randomized clinical study is necessary to confirm the benefit-risk balance for Imfinzi and is a condition of authorization.

For more information on Health Canadas decision, please view the Summary Basis of Decision.