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

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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