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, filed under the Notice of Compliance with Conditions (NOC/c) Policy, was to seek extension of the use of Keytruda (Pembrolizumab), as monotherapy, for the treatment of adult patients with refractory, relapsed classical Hodgkin Lymphoma who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV) or who are not ASCT candidates and have failed BV.
Why was the decision issued?
The results from a Phase II trial (KEYNOTE-087) and a Phase Ib trial (KEYNOTE-013) were provided to support efficacy and safety of Keytruda in treatment of patients with relapsed, refractory classical Hodgkin Lymphoma (cHL).
Objective response rate (ORR) was 58.1% (18/31 patients) and complete remission rate (CRR) was 19.4% (6/31 patients) from the KEYNOTE-013 trial. Median duration of response (DOR) was not reached. ORR and CRR was 68.1% (143/210 patients) and 21.9% (46/210 patients), respectively, from the KEYNOTE-087 trial. Median DOR was not reached after a median follow-up of 7.1 months.
The safety results reported among the patients with cHL remained consistent with the results previously reported for Keytruda from patients with other solid tumours. The overall number, type, and frequency of adverse events and serious adverse events reported among the patients with cHL are not indicative of any new safety concerns. Cases of graft versus host disease and veno-occlusive disease of the liver (including one fatal case for each) were reported in the cHL patients who received allogeneic stem cell transplant post Keytruda therapy. The causality to Keytruda treatment is unclear.
Promising efficacy of Keytruda, as monotherapy, in treatment of adult patients with refractory, relapsed cHL, who have unmet medical needs, has been demonstrated and the safety profile of Keytruda in the treatment of cHL patients is similar to that established from the treatment of patients with other solid tumours. The results of an on-going, Phase III confirmatory trial in cHL patients may further confirm the favourable benefit/risk profile of Keytruda. A Notice of Compliance with Conditions has been issued.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.