Regulatory Decision Summary for Bavencio
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 in Canada for Bavencio as a maintenance treatment for patients who have received the first-line chemotherapy. After evaluation of the submitted data package, Health Canada authorized Bavencio for the following indication:
Bavencio is indicated for the maintenance treatment of patients with unresectable locally advanced or metastatic urothelial carcinoma whose disease has not progressed following first-line platinum-based chemotherapy.
Why was the decision issued?
Authorization was based on an international, multi-centre, randomized, open label, phase 3 trial. Patients with unresectable locally advanced or metastatic urothelial carcinoma (UC) whose disease did not progress after completion of first-line platinum-containing chemotherapy were enrolled. Patients were randomized to receive either Bavencio 10 mg/kg intravenous infusion every 2 weeks plus best supportive care (BSC) (n = 350) or BSC alone (n = 350).
Bavencio maintenance therapy plus BSC demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as compared to BSC alone. Median OS improved by 7.1 months.
The most frequently reported adverse reactions (≥20%) in Bavencio-treated patients were fatigue, musculoskeletal pain, urinary tract infection, and rash. The safety results of Bavencio in the current study was consistent with the known safety profile of Bavencio. In general, adverse reactions were manageable.
The Canadian Product Monograph has been updated with the key safety and efficacy findings from this study.
Overall, the benefit/risk profile of Bavencio as maintenance therapy is considered positive in patients with unresectable locally advanced or metastatic UC whose disease has not progressed following first-line platinum-containing chemotherapy.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.