Regulatory approval

Published by the Health Service Executive. Approved

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

This is written in the approval document.

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