Regulatory Decision Summary for Imfinzi
Review decision
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.
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What was the purpose of this submission?
In accordance with the Notice of Compliance with Conditions (NOC/c) policy, the sponsor submitted data to fulfill a previously agreed upon commitment to provide confirmatory evidence of efficacy to support the conversion of the conditional authorization of Imfinzi (durvalumab) to authorization without conditions for the treatment of patients with locally advanced unresectable stage III non-small cell lung cancer (NSCLC) whose disease has not progressed after platinum-based chemoradiation.
Why was the decision issued?
Imfinzi (durvalumab) was authorized, for the treatment of patients with locally advanced stage III unresectable NSCLC who have not progressed after platinum-based chemoradiation, based on improved outcomes demonstrated in a phase III randomized clinical trial. The clinical trial, PACIFIC, demonstrated that Imfinzi monotherapy is associated with improved overall survival (OS) and progression-free survival (PFS) when compared to placebo. The findings of improved OS and longer PFS were considered to be clinically meaningful especially given the lack of any meaningful advancements in the treatment of this disease over several decades.
There is some remaining uncertainty regarding the efficacy (OS) of Imfinzi within a certain subgroup of patients who express the target of durvalumab (PD-L1) at very low levels; however, benefit was observed in the majority of subgroups examined including among patients of advanced age, various histologies and/or a history of smoking.
The overall safety profile for Imfinzi is consistent with the safety profiles of other products that target the PD-l/PD-L1 signalling axis. Immune-mediated events are common but can be managed by close monitoring, dose interruptions and the use of corticosteroids or hormone replacement therapies where necessary. In some instances, permanent discontinuation of therapy is required. The Product Monograph remains the primary source for risk mitigation measures related to Imfinzi monotherapy and its indicated uses.
Based on the clinically and statistically significant findings of PACIFIC and considering the well-characterized and manageable safety profile of durvalumab monotherapy, the benefit-risk balance for durvalumab monotherapy as consolidation therapy for stage III unresectable NSCLC that has not progressed after concurrent platinum-based chemoradiation was determined to be favourable.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.