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?
The purpose of this submission was to seek authorization for a new indication of Keytruda (pembrolizumab) for the adjuvant treatment of patients with Stage III melanoma with lymph node involvement who have undergone complete resection.
Why was the decision issued?
Authorization was based on the pre-defined interim analysis results from KEYNOTE-054 study, an international, multi-center, randomized, double-blind, placebo-controlled trial. Patients (N = 1,019) with complete resection of stage IIIA (>1 mm Lymph Node metastasis), IIIB and IIIC melanoma received either Keytruda 200 mg or placebo (normal saline) intravenously every 3 weeks for 18 administrations (~1 year) or until disease recurrence or unacceptable toxicity.
Primary efficacy endpoints were Recurrence-Free Survival (RFS) in all Intention-to-treat (ITT) subjects and ITT subjects with PD-L1 positive tumors. In the pivotal study, the Keytruda provides statistically significant improvement in RFS by decreasing the risk of death or recurrence by 43% compared to placebo. The median RFS was not reached in pembrolizumab group compared with 20.4 months in the placebo group in all ITT population. The median RFS was not reached in both pembrolizumab and placebo group in PD-L1 positive ITT population.
The overall safety profile is comparable to the established Keytruda data from prior clinical trials with other indications.
Key safety and efficacy findings were adequately labeled in Keytruda product monograph.
Overall results from KEYNOTE-054 study are considered sufficient to establish a positive risk/benefit assessment in the sought indication for the adjuvant treatment of patients with Stage III melanoma with lymph node involvement who have undergone complete resection.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.