Regulatory approval
Published by the Health Canada.
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
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Type | Biomarker(s) | Cancer type | Therapy(ies) |
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