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?
The purpose of this submission was to obtain market authorization for Imfinzi (durvalumab), an anti-PD-L1 monoclonal antibody, to treat patients with locally advanced unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy. The submission was granted advanced consideration in accordance with the Notice of Compliance with Conditions (NOC/c) policy.
*This was the second of two New Drug Submissions filed in close proximity to one another. The review focused only on safety and efficacy since other aspects (chemistry and manufacturing, non-clinical and clinical pharmacology) were reviewed under the first submission (control number 202953).
Why was the decision issued?
The PACIFIC study is a Phase III, randomized, double-blind, placebo-controlled, multi-centre, international clinical trial that enrolled 713 patients with unresectable locally advanced non-small cell lung cancer (NSCLC) who had not progressed following platinum-based chemoradiation therapy. Patients were randomized 2:1 to receive 10 mg/kg Imfinzi (n = 476) or placebo (n = 237) via intravenous infusion every 2 weeks for up to 12 months or until unacceptable toxicity or disease progression. Patients treated with Imfinzi had a statistically significant improvement in median progression-free survival (16.8 months) compared to patients treated with placebo (5.6 months). The study is ongoing for overall survival and a survival benefit of Imfinzi over placebo has not yet been established.
Imfinzi was generally well-tolerated in patients with locally advanced NSCLC. Pneumonitis is frequently observed in patients receiving radiation therapy to the lung and the clinical presentation of radiation-induced pneumonitis is very similar to other forms of pneumonitis, including immune-mediated events due to Imfinzi. Exacerbation of radiation-induced pneumonitis by Imfinzi is possible and an increase in total pneumonitis events were reported in NSCLC patients treated with Imfinzi vs. patients treated with placebo. Other safety signals reported in NSCLC patients treated with Imfinzi were consistent with the known safety profile of this PD-L1 inhibitor.
The results of the Phase III PACIFIC study support promising evidence of efficacy with an acceptable safety profile for Imfinzi in the treatment of patients with locally advanced unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation therapy.
A Notice of Compliance (NOC) according to the Notice of Compliance with Conditions (NOC/c) policy was recommended.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.