Regulatory Decision Summary for Sarclisa
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 Supplement to a New Drug Submission (SNDS) was to seek market authorization for Sarclisa (isatuximab for injection), in combination with carfilzomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Based on a joint review conducted under the Australia, Canada, Singapore, Switzerland, and United Kingdom (Access) Consortium new active substance work sharing initiative (NASWSI), by the Therapeutic Goods Administration (TGA, Australia), Health Canada, and the Swissmedic (Switzerland), Health Canada authorized Sarclisa for the following indication:
- Sarclisa (isatuximab for injection) is indicated in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
Why was the decision issued?
Authorization was based on the results of a multicenter, multinational, randomized, open-label, 2-arm, phase III study in adult patients with relapsed and/or refractory multiple myeloma who had received 1 to 3 prior lines of therapy.
The primary efficacy endpoint was progression-free survival (PFS). The study met its primary endpoint as treatment with Sarclisa in combination with carfilzomib and dexamethasone (Isa-Kd) resulted in a 46.9% reduction in the risk of disease progression or death compared with the control treatment of carfilzomib and dexamethasone (Kd). This result was statistically significant and considered to be a clinically meaningful result in patients with relapsed or refractory disease.
The addition of Sarclisa to carfilzomib and dexamethasone resulted in a higher incidence of severe adverse reactions; however, serious adverse reactions occurred at similar rates between the treatment arms. The most frequent adverse reactions reported in patients treated with Isa-Kd were infusion-related reactions (IRRs); however, all IRRs resolved. Second primary malignancies (SPMs) were reported more frequently in the Isa-Kd group compared to the Kd group. A warning regarding the risk of SPMs was added to the Warnings and Precautions section of the Sarclisa Product Monograph. The safety profile of the Isa-Kd regimen was generally consistent with the known safety profile of Sarclisa and that of carfilzomib in combination with dexamethasone.
Overall, the benefit/risk profile for Sarclisa, in combination with carfilzomib and dexamethasone, is considered favourable for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations