Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved midostaurin in combination with intermediate dose cytarabine consolidation chemotherapy for reimbursement as a treatment option for the treatment of adult patients newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation positive

This is written in the approval document as:

Midostaurin is indicated in combination with intermediate dose cytarabine consolidation chemotherapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive

Reimbursement

Incomplete Reimbursement

Midostaurin - CDS 2021-10-01; Cytarabine - N/A

Citation

Midostaurin and Intermediate Dose Cytarabine Consolidation Therapy, 2025, version number 2b, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6999/683_v2b_Midostaurin_Intermediate_dose_Cytarabine_Consolidation_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	Cytarabine, Daunorubicin, Midostaurin

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2021-10-01	Health Service Executive	Indication approved for reimbursement.