Regulatory approval

Published by the Health Service Executive. Approved

As monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation. In the event that patients re-initiate gilteritinib post haematopoietic stem cell transplant (HSCT) as maintenance therapy, gilteritinib treatment should be restricted to patients who are minimal residual disease (MRD)-positive post-transplant.

This is written in the approval document.

Reimbursement

CDS

Citation

Gilteritinib Therapy, 2025, version number 1, viewed 26/03/2026, https://healthservice.hse.ie/documents/7000/684_v1_Gilteritinib_Therapy.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	Gilteritinib
HSE (1)	FLT3 p.D835Y	Acute Myeloid Leukemia	Gilteritinib

Contributions

Date	Contributor	Description
2025-10-01	Health Service Executive	Indication approved for reimbursement.
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database