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, 2022, version number 2, NCCP National SACT Regimen, NCCP, viewed 15/04/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/leukemia-bmt/538-blinatumomab-therapy.pdf

Therapeutic response

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

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