Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved midostaurin in combination with standard daunorubicin and cytarabine induction chemotherapy for reimbursement as a treatment option for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive.

This is written in the approval document as:

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.

Citation

Midostaurin, DAUNOrubicin and Cytarabine Induction Therapy, 2023, version number 3, NCCP National SACT Regimen, NCCP, viewed 08/01/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/leukemia-bmt/682.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) FLT3-ITD Acute Myeloid Leukemia Cytarabine, Daunorubicin, Midostaurin