Regulatory approval

Published by the Health Service Executive. Approved

As monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive B-precursor acute lymphoblastic leukaemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%

This is written in the approval document.

Reimbursement

ODMS

Citation

Blinatumomab Therapy (ALL with MRD >= 0.1%), 2025, version number 2a, NCCP National SACT Regimen, NCCP, viewed 02/08/2026, https://healthservice.hse.ie/documents/6987/590_v2a_Blinatumumab_Therapy.pdf

Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
HSE (1) CD19 +, not BCR::ABL1 Acute Lymphoid Leukemia Blinatumomab