Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved blinatumomab for reimbursement as a monotherapy treatment option for the treatment of pediatric patients aged 1 year or older with high-risk first relapsed with Philadelphia chromosome negative CD19 positive B-precursor acute lymphoblastic leukemia (ALL) as part of the consolidation therapy.

This is written in the approval document as:

As monotherapy for the treatment of paediatric patients aged 1 year or older with high-risk first relapsed Philadelphia chromosome negative CD19 positive B-precursor acute lymphoblastic leukaemia (ALL) as part of the consolidation therapy.

Citation

Blinatumomab for Relapsed Paediatric ALL: Consolidation Therapy, 2022, version number 1, NCCP National SACT Regimen, NCCP, viewed 04/04/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/paediatric/707-blinatumomab-rall-consolidation-therapy.pdf

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Therapeutic response

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

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) BCR::ABL1, CD19 + Acute Lymphoid Leukemia Blinatumomab