Regulatory Decision Summary for Blincyto
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 the submission was to seek approval for BLINCYTO for the treatment of adults with Philadelphia chromosome-negative relapsed or refractory B precursor acute lymphoblastic leukemia (ALL). Advance consideration under the Notice of Compliance with Conditions Policy was granted following pre-submission meetings with Biologics and Genetic Therapies Directorate (BGTD) in which the sponsor presented data from a single-arm clinical study to demonstrate promising clinical benefit.
Why was the decision issued?
Data from a phase 2, single-arm clinical trial has demonstrated that BLINCYTO is a promising immunotherapeutic agent for the treatment of adult patients with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL). For this patient population with a historically poor prognosis, there are very few treatment options. In the pivotal trial, a clinically meaningful rate of remission was achieved within 2 treatment cycles of BLINCYTO. Data from an on-going confirmatory Phase 3 randomized trial is needed to establish the benefit of blinatumomab over current therapies. Although treatment with BLINCYTO is associated with significant adverse events, most can be managed with close monitoring and early intervention. The promising treatment benefit in adult patients with relapsed/refractory B-precusor ALL, in combination with a safety profile that is considered manageable, demonstrate a favorable benefit/risk profile and meets the NOC/c criteria of demonstrating a promising clinical benefit for patients with a serious, life-threatening disease who are unresponsive to or unable to tolerate existing therapies.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| BLINCYTO | 02450283 | AMGEN CANADA INC | BLINATUMOMAB 38.5 MCG / VIAL |