publication date: Jan. 16, 2016
Blincyto Receives Conditional Approval from Health Canada
Health Canada granted conditional approval of Blincyto (blinatumomab) for the treatment of adults with Philadelphia chromosome-negative relapsed or refractory B precursor acute lymphoblastic leukemia.
With this approval, Blincyto becomes the first Health Canada-approved bispecific CD19-directed CD3 T-cell engager antibody construct product, and the first single-agent immunotherapy to be approved for the treatment of patients with Ph- relapsed or refractory B precursor ALL.
The conditional approval is received under Health Canada’s Notice of Compliance with conditions policy which allows for earlier marketing of promising drugs for serious conditions before the drugs have definitively demonstrated clinical efficacy. Amgen Canada Inc., the application’s sponsor, has made commitments to complete confirmatory trials to convert the approval to a full notice of compliance.
Bispecific T cell engager, or BiTE, antibody constructs are being investigated for helping the body’s immune system detect and target malignant cells. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells to cancer cells.
FDA granted Priority Review to venetoclax for the treatment of chronic lymphocytic leukemia in adults who have received at least one prior therapy, including patients with 17p deletion.
With priority review, the FDA’s goals include a faster timeline for review of six months, compared to 10 months for the standard review period.
Additionally, the European Medicines Agency validated venetoclax Marketing Authorization Application for the treatment of patients with chronic lymphocytic leukemia with 17p deletion or TP53 mutation.
… Continue reading 42-02 Blincyto Receives Conditional Approval from Health Canada
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