Regulatory Decision Summary for KEYTRUDA
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 the submission was to file a market application for KEYTRUDA for the indication of treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor.
Why was the decision issued?
The KEYNOTE 001 Study demonstrated an objective response rate of 24% (95% confidence interval: 15%, 34%) consisting of 1 complete response and 20 partial responses. For these patients with unresectable or metastatic melanoma that has progressed after ipilimumab and BRAF or MEK inhibitors for BRAF-mutant disease, very few treatment options remain. These findings, in combination with an overall safety profile that is considered manageable, meets the Health Canadas Notice of Compliance with condition (NOC/c) criteria of promising clinical benefit as a second or third line (if BRAF V600 mutation) treatment for unresectable or metastatic melanoma which is a life threatening disease.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.