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?
The purpose of this SNDS is to support the extension of the use of Keytruda under the Notice of Compliance with Conditions Policy (NOC/c), for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours express programmed death ligand 1 (PD-L1) (as determined by a validated test, see Dosage and Administration) and who have disease progression on or after platinum-containing chemotherapy. Patients with epithelial growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations should have disease progression on authorized therapy for these aberrations prior to receiving Keytruda.
Why was the decision issued?
Metastatic Non-Small Cell Lung Cancer (NSCLC) is a serious and life-threatening disease. Patients who experienced a disease progression have limited therapeutic options, and they eventually die from their disease. The pivotal trial KEYNOTE-001 submitted in support of the proposed indication demonstrated a promising objective response rate (ORR) of 41% in patients whose tumours expressed PD-L1 (Tumour Proportion Score [TSP] ≥50%). The median duration of response was not reached at the time of the analysis, but the response lasted between 2.1 and 9.1 months among the responders. An improvement in survival or disease-related symptoms has not been established.
The safety profile of Keytruda is considered manageable in the context of metastatic NSCLC. The most common adverse events (AEs) were fatigue, decreased appetite, dyspnea, rash, cough, nausea, diarrhea, arthralgia, and constipation. Immune-mediated AEs including pneumonitis, colitis, endocrinopathies, severe skin reactions, vasculitis, autoimmune hemolytic anemia, myasthenic syndrome and serum sickness were observed in NSCLC patients treated with Keytruda. Other immune-mediated AEs such as hepatitis, nephritis, uveitis, Type I diabetes mellitus, pancreatitis, bullous pemphigoid and Guillain-Barre syndrome were also observed in other Keytruda clinical trials.
In view of the promising efficacy outcome and a manageable safety profile, the overall risk benefit profile of Keytruda is favourable, and meets the NOC/c criteria of promising clinical benefit, for previously treated metastatic NSCLC whose tumours express PD-L1 (TPS ≥50%). Patients with EGFR or ALK genomic tumor aberrations should have disease progression on authorized therapy for these aberrations prior to receiving Keytruda.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.