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 Supplemental New Drug Submission (SNDS) was to seek a conditional market authorization for Keytruda (pembrolizumab) for the treatment of adult patients with Bacillus Calmette-Guerin-unresponsive, high-risk, non-muscle invasive bladder cancer. The submission was granted advanced consideration in accordance with the Notice of Compliance with Conditions policy. After evaluation of the submitted data package, Health Canada authorized, with conditions, Keytruda for the following indication: for the treatment of adult patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in-situ (CIS) with or without papillary tumours who are ineligible for or have elected not to undergo cystectomy.
Why was the decision issued?
Conditional authorization was based on the results of a phase 2, single arm, multi-site, open-label trial, designed to assess efficacy and safety of Keytruda monotherapy in patients with BCG-unresponsive high-risk NMIBC with CIS (with or without papillary tumours) who are ineligible for, or elect not to undergo, cystectomy. Keytruda was administered at a dose of 200 mg by intravenous infusion every 3 weeks until disease progression, unacceptable toxicity or up to 24 months, in patients without disease progression.
The primary efficacy endpoint was complete response (CR) rate for patients who met the defined criteria for high-risk BCG-unresponsive NMIBC with CIS (n = 96). The CR rate was 40.6%. This was supported by a median duration of response of 16.2 months. Of the patients who achieved a CR, 69.2% and 46.2% had responses that lasted at least 6 and 12 months respectively. The safety profile was consistent with the known safety profile of Keytruda monotherapy, and no new safety signals were identified. The risks associated with Keytruda monotherapy in the target patient population have been appropriately captured and communicated in the Product Monograph (PM).
The magnitude of the treatment effect demonstrates promising evidence of a positive benefit in the target patient population. The evidence provided shows a promising benefit/risk profile for the proposed patient population. As a condition of authorization, the sponsor will be required to commit to file phase 3 trial data to confirm the efficacy of Keytruda in patients with high-risk NMIBC.
The recommend dose of Keytuda for the authorized indication is 200 mg every three weeks (Q3W). See the Product Monograph for details.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.