Regulatory approval

Published by the Health Service Executive. Approved

Midostaurin is indicated as single agent maintenance therapy for adult patients with FLT3 mutation positive acute myeloid leukaemia (AML) in complete response after completion of induction and consolidation chemotherapy.

This is written in the approval document.

Reimbursement

CDS

Citation

Midostaurin Maintenance Therapy, 2025, version number 2a, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6997/661_v2a_Midostaurin_Maintenance_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 Midostaurin