Blincyto (blinatumomab) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

Amgen Canada Inc. Blincyto (blinatumomab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00078156.PDF. Revised December 2024. Accessed June 2025.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
BLINCYTO (blinatumomab for injection) is indicated for the treatment of patients with Philadelphia chromosome-negative CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy.
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%.
BLINCYTO (blinatumomab for injection) is indicated for the treatment of adult patients with relapsed or refractory B-cell precursor ALL.	1
BLINCYTO (blinatumomab for injection) is indicated for the treatment of pediatric patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor ALL.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	CD19 +	Acute Lymphoid Leukemia	Blinatumomab