Therapeutic Response

FLT3-ITD status confers therapeutic sensitivity to Cytarabine in combination with Daunorubicin and Midostaurin in patients with Acute Myeloid Leukemia.

Statements

Source and description
Rydapt (midostaurin) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to midostaurin in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive, as detected by an FDA-approved test. Midostaurin's product label notes that midostaurin is not indicated as a single-agent induction therapy for the treatment of patients with AML.
Rydapt (midostaurin) [product information]. EMA. The European Medicines Agency (EMA) has authorized midostaurin in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by midostaurin single agent maintence therapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive. Midostaurin's product information further states that AML patients must have confirmation of the FLT3 mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test.
Midostaurin, DAUNOrubicin and Cytarabine Induction Therapy. NCCP National SACT Regimen. HSE. 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.