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 adult patients with relapsed or refractory B cell precusor (BCP) Philadelphia chromosome negative acute lymphoblastic leukemia (ALL) who have received no prior salvage treatment for relapsed / refractory (R/R) disease and are considered eligible for transplant (e.g., as a bridge-to-transplant).

This is written in the approval document as:

Treatment of adult patients with relapsed or refractory B cell precursor (BCP) Philadelphia chromosome negative acute lymphoblastic leukaemia (ALL) who have received no prior salvage treatment for relapsed/refractory (R/R) disease and are considered eligible for transplant (i.e. as a bridge-to-transplant).

Citation

Blinatumomab Therapy, 2025, version number 2a, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6982/538_v2a_Blinatumomab_Therapy.pdf

Therapeutic response

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

Organization(s) Biomarker(s) Cancer type Therapy(ies)
HSE (1) BCR::ABL1 Acute Lymphoid Leukemia Blinatumomab