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?
This new drug submission was filed under the Notice of Compliance with Conditions (NOC/c) policy to seek conditional market authorization for Bavencio (avelumab), an anti-PD-L1 monoclonal antibody for the treatment of adult patients with metastatic Merkel Cell Carcinoma (MCC). Upon review, the following indication is authorized:
Bavencio(avelumab) is indicated for the treatment of metastatic Merkel Cell Carcinoma (MCC) in previously treated adults.
The NOC/c was based on tumour response and durability of response. An improvement in survival or disease-related symptoms has not yet been established.
Why was the decision issued?
Merkel Cell Carcinoma (MCC) is a rare and aggressive neuroendocrine tumor of the skin. One-third of patients will develop a distant metastasis which is serious and life-threatening with poor prognosis. In Canada, there are no approved treatment options nor are there any chemotherapy regimens that demonstrate durable response or survival benefit for metastatic MCC.
The efficacy and safety of Bavencio (avelumab) were evaluated in an open-label, single-arm, multi-center study in 88 patients previously treated for metastatic MCC. Best overall response was confirmed in 29 patients (33.0% response rate). A total of 21 patients (23.9%) remained in response at 12 months after the start of treatment.
The safety of Bavencio was characterized with data from 88 trial patients previously treated for their metastatic MCC and supported by a safety database comprising a total of 1,738 patients who had been treated with Bavencio for solid tumors including metastatic MCC. The risks associated with Bavencio are primarily due to its inhibitory effects on PD-L1. Immune-mediated adverse drug reactions (imARs) and infusion reactions (IRs) are the two primary safety risks of avelumab. Reported imARs associated with Bavencio treatment include pneumonitis, myocarditis, endocrinopathies (thyroid disorders, adrenal insufficiency and Type I diabetes mellitus), hepatitis, colitis, nephritis, myositis and skin reactions. The frequency, severity, duration and types of imARs associated with Bavencio are, in general, consistent with those reported for anti-PD-1/PD-L1 inhibitors.
The risks associated with Bavencio are appropriately captured in the Bavencio Product Monograph and are, in general, manageable. Proper risk mitigation/management and post marketing surveillance for imARs and IRs are included in the Product Monograph and the Risk Management Plan for Bavencio. Overall, the benefit/risk profile of Bavencio is acceptable for the recommended indication in accordance with Health Canadas NOC/c policy.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| BAVENCIO | 02469723 | EMD SERONO, A DIVISION OF EMD INC., CANADA | AVELUMAB 20 MG / ML |