Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that FLT3 p.D835N status confers therapeutic sensitivity to Cytarabine, Daunorubicin, Midostaurin in patients with Acute Myeloid Leukemia.
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.
This statement is based on a regulatory approval from the Food and Drug Administration:
RYDAPT is a kinase inhibitor indicated 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, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML.