Regulatory Decision Summary for Tecentriq

For patients with locally advanced or metastatic urothelial carcinoma who have progressed during or after platinum-based chemotherapy there are few treatment options. No treatments have been previously authorized in this setting in Canada. Single-agent regimens have been tested in single-arm, phase II trials and are associated with low rates of response and significant toxicities. Doublet regimens are associated with higher rates of response but increase toxicity and do not appear to improve survival compared to single-agent regimens. In addition, it is recognised that many patients in this setting are unable to receive systemic chemotherapy. For these patients, best supportive care or enrollment in a clinical trial is the preferred course of action. Therefore, new treatment options are clearly needed.

Tecentriq (atezolizumab) was associated with a modest overall response rate (ORR) in a heavily pre-treated, difficult to treat population. The observed responses were durable compared to previously reported responses obtained with salvage chemotherapy. The safety profile of Tecentriq has been well characterized in the clinical trial setting, is consistent with other products in the class, and is manageable with close monitoring and prompt intervention. Given the lack of therapeutic options available to patients within the indication, the evidence provided in support of the efficacy of Tecentriq is considered promising such that the tentative benefit-risk balance can be considered favourable. Confirmation of efficacy in a well-controlled, randomized clinical study is necessary to confirm the benefit-risk balance for Tecentriq and is a condition of authorization.

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