Gilteritinib Therapy. NCCP National SACT Regimen. HSE.

Regulatory approval published by the Health Service Executive.

Citation

Gilteritinib Therapy, 2025, version number 1, viewed 01/10/2025, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/leukemia-bmt/684-gilteritinib-therapy.pdf

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	FLT3-ITD	Acute Myeloid Leukemia	Gilteritinib
Sensitivity (+)	FLT3 p.D835Y	Acute Myeloid Leukemia	Gilteritinib