Regulatory approval

Published by the Health Canada. Approved

Health Canada approved blinatumomab for the treatment of patients with Philadelphia chromosome-negative CD19-positive B-cell precursor ALL in first or second hematologic complete remission with minimal residual disease (MRD) >= 0.1%, as determined by an accredited laboratory using validated assay methods.

This is written in the approval document as:

BLINCYTO (blinatumomab for injection) is indicated for the treatment of patients with Philadelphia chromosome-negative CD19 positive B-cell precursor ALL in first or second hematologic complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.

Citation

Amgen Canada Inc. Blincyto (blinatumomab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00083697.PDF. Revised February 2026. Accessed April 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies

Contributions

Date	Contributor	Description