Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved quizartinib in combination with standard idarubicin and cytarabine induction chemotherapy as a treatment option for the treatment of adult patients with newly diagnose acute myeloid leukaemia (AML) who are FLT3-ITD mutation positive.

This is written in the approval document as:

Quizartinib in combination with standard IDArubicin and cytarabine induction chemotherapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3-ITD mutation positive.

Reimbursement

Incomplete Reimbursement

Quizartinib - CDS; idarubicin and cytarabine - N/A

Citation

Quizartinib, IDArubicin and Cytarabine Induction Therapy, 2026, version number 2, NCCP National SACT Regimen, NCCP, viewed 02/08/2026, https://healthservice.hse.ie/documents/7020/891_Quizartinib_Induction_IDArubicin.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	FLT3-ITD	Acute Myeloid Leukemia	Cytarabine, Idarubicin, Quizartinib

Contributions

Date	Contributor	Description
2026-08-02	Van Allen lab	Initial curation of into moalmanac-db
2025-02-01	Health Service Executive	Indication approved for reimbursement.