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 New Drug Submission (NDS) is to support the use of Darzalex under the Notice of Compliance with Conditions Policy (NOC/c), for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are refractory to both a PI and an IMiD.
Why was the decision issued?
Multiple myeloma (MM) is a progressive and life-threatening disease. Once these patients relapsed or become refractory to available therapeutic options including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), limited treatment options remain to these heavily pre-treated patients. The pivotal trial MMY2002 submitted in support of the proposed indication demonstrated a promising objective response rate (ORR) of 29.2% in patients with MM who have received at least three prior lines of therapy including a PI and an IMiD, or who are refractory to both a PI and an IMiD. Among the 31 responders, the median duration of response was 7.4 months.
The safety profile of Darzalex is considered manageable in the context of relapsed/refractory MM. The most common adverse events (AEs) were infusion-related reactions (IRRs), fatigue, pyrexia, cough, nasal congestion, dyspnea, back pain, arthralgia, upper respiratory tract infection, nasopharyngitis, diarrhea, anemia, neutropenia and thrombocytopenia. Severe IRRs included bronchospasm, hypertension, dyspnea and hypoxia. The most frequently reported serious AEs were infections (e.g. pneumonia and herpes zoster), general physical health deterioration, pyrexia, hypercalcemia and crossmatch incompatible. Darzalex binds to CD38 on red blood cells and may result in a positive indirect Coombs test that may persist for up to 6 months after the last Darzalex infusion. Darzalex can also be detected on both the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein. This interference can impact the determination of disease response in patients with IgG kappa myeloma protein.
In view of the promising efficacy outcome and a manageable safety profile, the overall risk benefit profile of Darzalex is favourable, and meets the NOC/c criteria of promising clinical benefit, for patients with MM who have received at least three prior lines of therapy including a PI and an IMiD, or who are refractory to both a PI and an IMiD.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Decision issued
Approved; issued Notice of Compliance with Conditions (NOC/c) in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| DARZALEX | 02455978 | JANSSEN INC | DARATUMUMAB 400 MG / 20 ML |
| DARZALEX | 02455951 | JANSSEN INC | DARATUMUMAB 100 MG / 5 ML |