Regulatory Decision Summary for AVASTIN

What was the purpose of this submission?
The purpose of this submission was to seek Health Canadas authorization to remove conditions to a Notice of Compliance with Conditions (NOC/c) for use of Avastin, as a single agent, for the treatment of patients with glioblastoma (GBM) after relapse or disease progression, following prior therapy.

What did the company submit to support its submission?
The results from a phase III clinical trial in patients with recurrent glioblastoma were provided. Clinical efficacy and safety of Avastin in combination with lomustine was compared with lomustine monotherapy in the study. Additional data from clinical studies of Avastin in combination with chemoradiotherapy in patients with newly diagnosed glioblastoma were also provided as supporting information.

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, Health Canada completed the assessment of the data provided to support the removal of the conditions. The clinical efficacy and safety data of Avastin in combination with lomustine as demonstrated in the proposed confirmatory trial are not considered as appropriate evidence to confirm the clinical benefit of using Avastin as a single agent in the treatment of patients with recurrent GBM.

What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
Health Canada has authorized a new indication for Avastin in combination with lomustine for the treatment of patients with recurrent GBM to address the unmet medical need. Please refer Regulatory Decision Summary for SNDS control# 207259 for more information. This decision is not expected to impact SAP or clinical trial access to this drug.

Additional information

*Proposed Brand Name
Avastin

Manufacturer
Hoffman La-Roche Limited

Date filed
July 4, 2017