Regulatory Decision Summary for Avastin
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:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
This Supplemental New Drug Submission (SNDS) was filed to seek marketing authorization of Avastin, in combination with lomustine, for the treatment of patients with glioblastoma after relapse or disease progression, following prior therapy. Upon review, the indication was approved.
The indication of Avastin, as a single agent, for the treatment of patients with glioblastoma after relapse or disease progression, following prior therapy, which was previously authorized by Health Canada under Notice of Compliance with Conditions policy, has been withdrawn. See Summary of Cancellation for additional information.
Why was the decision issued?
Clinical efficacy and safety data from Study EORTC 26101 were provided to support the proposed indication. Study EORTC 26101 was a randomized, two-arm, open-label, multicenter Phase III study to investigate efficacy and safety of the addition of Avastin to lomustine in the treatment of patients with recurrent glioblastoma (GBM). The study did not demonstrate a statistically significant and clinically meaningful improvement in overall survival (OS). Given the current clinical context, the regulatory decision was based on a clinically meaningful improvement in investigator-assessed progression-free survival, a higher objective response rate, and more patients who either reduced or discontinued corticosteroids from baseline in the combination arm. The clinical benefit of Avastin in the treatment of recurrent GBM was also considered in the context of unmet medical needs.
The safety profile of Avastin in the treatment of recurrent GBM patients was characterized. As expected, more AEs, SAEs and AEs with special interest were reported with the Avastin and lomustine combination arm. Overall, the safety profile of Avastin in combination with lomustine observed in Study EORTC 26101 was consistent with previous experience of Avastin in patients with recurrent GBM and with the known safety profile of Avastin across other tumour types. No new or unexpected AEs were observed from the study.
In conclusion, based on the data provided in this SNDS, taking into consideration the devastating nature of recurrent GBM with very limited effective therapeutic options, the benefit risk profile of Avastin in combination with lomustine in the treatment of patients with recurrent GBM is judged to be clinically favourable, and an NOC was issued.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.