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?
Merck Canada filed a Supplemental New Drug Submission (SNDS), for advance consideration of Notice of Compliance with conditions (NOC/c) for Keytruda (pembrolizumab), indicated for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma, as monotherapy, in adults who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD L1 [Combined Positive Score (CPS) ≥10] as determined by a validated test, or in adults who are not eligible for any platinum containing chemotherapy regardless of PD L1 status.
Why was the decision issued?
Authorization was based on results from a pivotal phase II study in patients with locally advanced unresectable or metastatic urothelial carcinoma who were ineligible for cisplatin-containing chemotherapy. A total of 370 subjects were enrolled and treated with pembrolizumab monotherapy 200 mg every 3 weeks until unacceptable toxicity or disease progression.
The primary efficacy outcome measure was Objective Response Rate (ORR) as assessed by the blinded independent central radiology review. The ORR was 28.9%, with a complete response rate of 8% among all treated subjects. The median overall survival (OS) was 11.5 months in the overall population. A total of 110 study subjects had tumors expressing PD-L1 combined positive score (CPS)≥10. Among these subjects, the ORR was estimated to be 47% and the median OS was 18.5 months, approximately.
Overall the safety profile of pembrolizumab observed among patients with cisplatin ineligible urothelial carcinoma was consistent with the established profile. No new safety signal was identified.
There is an unmet medical need in patients with locally advanced unresectable or metastatic urothelial carcinoma who are considered ineligible for cisplatin-containing chemotherapy. The study had shown a promising benefit-risk profile of pembrolizumab monotherapy in this patient population. Results of on-going phase 3 studies in the indicated population are committed to be submitted and may further confirm the favorable benefit-risk balance. Based on the totality of the evidence, an NOC/c was recommended.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.