Regulatory Decision Summary for Avelumab (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.
Product type:
Summary of Cancellation: avelumab (BAVENCIO)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
A Notice of Non-compliance (NON) was issued by Health Canada on April 02, 2020. The company cancelled the submission on June 30, 2020, prior to the final decision being issued.
Date of cancellation
2020/06/30
What was the purpose of this submission?
The purpose of this submission was to seek authorization for the marketing of Bavencio (avelumab), in combination with axitinib, as first-line treatment for patients with advanced Renal Cell Carcinoma (aRCC).
What did the company submit to support its submission?
The sponsor submitted data from the pivotal Phase 3 Study B9991003 (Javelin Renal 101): a multinational, multicenter, randomized, open-label, parallel 2-arm study which compared avelumab in combination with axitinib to sunitinib monotherapy as first-line treatment in patients with aRCC.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
At the time of the cancellation, a Notice of Non-compliance had been issued on April 02, 2020. Health Canada had identified some deficiencies in the data; the sponsor chose to cancel their submission in order to re-file at a later date with additional data.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There is no expected impact on patients using SAP or in clinical trials as Bavencio is currently authorized for use on the Canadian Market.