Regulatory Decision Summary for Darzalex / Darzalex SC
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 Darzalex (daratumumab) in combination with Kyprolis and dexamethasone (DKd) for use in the treatment of patients with relapsed multiple myeloma who have received 1 to 3 prior lines of therapy.
After evaluation of the submitted data package, Health Canada authorized Darzalex for the above indication.
Why was the decision issued?
The market authorization of Darzalex in combination with Kyprolis and dexamethasone (DKd) was based on the results of CANDOR, a pivotal Phase 3, open-label, multicenter trial, in patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy. A total of 466 patients were randomized: 312 to the DKd arm and 154 to the Kyprolis and dexamathesone (Kd) arm.
CANDOR showed subjects in the DKd group had a 37% reduction (95% confidence interval [CI]: 0.46, 0.85) in the risk of their disease progression compared to subjects in the Kd group, and the overall response rate was higher in the DKd group (84%) compared to the Kd group (75%).
The safety profile of Darzalex in combination with Kd was consistent with the safety information captured in the current Darzalex Product Monograph.
Overall, Darzalex in combination with Kd provides a treatment option that may delay the disease progression for some heavily treated MM patients.
Decision issued
Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.