Regulatory Decision Summary for Mekinist
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?
A Supplement to a New Drug Submission was submitted for Mekinist for a new indication for the treatment of patients with advanced non-small cell lung cancer (NSCLC) with a BRAF V600 mutation.
Why was the decision issued?
The safety and efficacy of Mekinist plus dabrafenib combination therapy for previously treated metastatic non-small cell lung cancer patients with a BRAFV600 mutation were evaluated in a single pivotal study (BRF113928). This study was a phase II open label non-comparative trial consisting of metastatic NSCLC patients who were sequentially enrolled in three cohorts. The primary efficacy endpoint was Objective Response Rate (ORR).
The ORR primary endpoint was 63.2% which exceeded the priori-defined statistical threshold for success of 55%. These results are robust given the high concordance with the endpoint as evaluated by an Independent Review Committee (IRC). The Median Duration of Response was 9.0 months.
Overall, the safety profile of the combination therapy was generally consistent with what has been observed in the other indications, with no new safety signals identified. Adverse events were generally manageable through dose adjustment, treatment interruption, or drug/non-drug intervention, with few discontinuations.
In conclusion, the combination of Mekinist plus dabrafenib demonstrated clinically meaningful and durable anti-tumor activity in metastatic NSCLC patients harbouring the BRAFV600 mutation whose disease had progressed on previous systemic therapy. The benefit-risk profile for this combination is considered favorable.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.