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.
Product type:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
This Supplement to a New Drug Submission - Confirmatory (SNDS-c) reviewed efficacy and safety data from an interim analysis of Study P002 for the use of Keytruda (pembrolizumab) in the treatment of unresectable and metastatic melanoma in patients who were previously treated and progressed after ipilimumab.
Why was the decision issued?
The decision was made to update the Keytruda product monograph with interim analysis results of the confirmatory study P002 which included the co-primary endpoint of progression free survival and safety data. The final study report, which will provide the analysis of the co-primary endpoint of overall survival, will be required to make an appropriate risk/benefit analysis for removing the condition for the use of Keytruda for the 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.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.