Regulatory Decision Summary for Bavencio
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Type of submission:
What was the purpose of this submission?
The purpose of this submission was to seek conditional market authorization for Bavencio (avelumab), an anti-PD-L1 monoclonal antibody, intended to treat patients with locally advanced or metastatic urothelial carcinoma who have received prior platinum-based chemotherapy. The submission was granted advanced consideration in accordance with the Notice of Compliance with Conditions policy.
Why was the decision issued?
Bavencio, 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. Bavencio was associated with a modest overall response rate (ORR) (16.1%) in a difficult to treat patient population. The safety profile of Bavencio 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. Bavencio 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 Bavencio 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 Bavencio and is a condition of authorization.
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.