Regulatory Decision Summary for Darzalex
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 submission was to seek market authorization for a new indication for Darzalex in newly diagnosed multiple myeloma (MM) patients who are ineligible for autologous stem cell transplant (ASCT).
After evaluation of the submitted package, Health Canada authorized Darzalex for the following indication:
- in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Why was the decision issued?
The authorization of Darzalex was based on the results of one multicentre, randomized, open-label phase 3 clinical trial, MMY3008. A total of 737 patients that were newly diagnosed with multiple myeloma (MM) who are ineligible for autologous stem cell transplant (ASCT) were randomized 1:1 to receive Darzalex in combination with lenalidomide and dexamethasone (DRd arm; n = 368) or lenalidomide and dexamethasone alone (Rd arm; n = 369). The median treatment duration was 25.3 months in the DRd arm and 21.3 months in the Rd arm.
The primary efficacy endpoint was progression-free survival (PFS). DRd arm resulted in a substantial improvement in PFS with a 44% reduction in the risk of progression or death over the Rd arm. The PFS benefit is consistent among patient subgroups and was supported by a higher overall response rate (ORR) in the DRd arm compared with the Rd arm.
The safety findings were consistent with those associated with Darzalex, and/or lenalidomide/dexamethasone.
In view of the statistically significant and clinically meaningful PFS benefit associated with an ORR improvement in the context of this disease in the frontline setting, as well as a manageable safety profile, the overall risk benefit profile of Darzalex in combination with lenalidomide and dexamethasone is favourable for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The recommended dose is 16 mg/kg of body weight administered as an intravenous infusion. View the Product Monograph for details.
Health Canada granted this application priority review in accordance with the priority review policy.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.