Regulatory approval

Published by the Health Service Executive. Approved

Midostaurin is indicated in combination with standard DAUNOrubicin and cytarabine induction 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; DAUNOrubicin, Cyarabine - N/A

Citation

Midostaurin, DAUNOrubicin and Cytarabine Induction Therapy, 2025, version number 3a, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6998/682_v3a_Midostaurin_DAUNOrubicin_and_Cytarabine_Induction_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.