Regulatory Decision Summary for Xgeva
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 the submission was to extend the use of Xgeva to include reducing the risk of developing skeletal-related events in patients with multiple myeloma.
Why was the decision issued?
Data from a phase III, randomized, active-controlled trial have demonstrated that Xgeva (denosumab) has similar efficacy to zoledronic acid, the third generation of bisphosphonate, for reducing the risk of time to first on-study skeletal-related event [Hazard ratio 0.98, (95% CI: 0.85-1.14)] in patients with multiple myeloma. The safety profile of denosumab is consistent with that reported in previous studies with cancer populations. Xgeva is associated with increased risks of hypocalcaemia, osteonecrosis of the jaw, and atypical femur fracture. Most of these adverse events can be managed or mitigated with preventive measures, close monitoring, and early intervention. The pharmacokinetics of denosumab are not affected by renal function. Xgeva can be used without restriction or dosing adjustment in patients with renal impairment. Therefore, the benefit/risk assessment is considered positive.
Based on the evaluation of the data submitted, and labelling agreed to during the review, this SNDS for Xgeva, for the indication of reducing the risk of developing skeletal-related events in patients with multiple myeloma, complies with the Food and Drug Regulations. A Notice of Compliance (NOC) was granted.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.