Therapeutic Response

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

Statements

Source and description
Vanflyta (quizartinib) [product information]. EMA. The European Medicines Agency (EMA) has authorized quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single-agent maintenance therapy for the treatment of adult aptients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.
Quizartinib, DAUNOrubicin and Cytarabine Induction Therapy. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved quizartinib in combination with standard daunorubicin and cytarabine induction therapy for reimbursement as a treatment option for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3-ITD mutation positive.
Vanflyta (quizartinib) [package insert]. FDA. The U.S. Food and Drug Administration (FDA) granted approval to quizartinib in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as a maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test. This indication is based on QuANTUM-First (NCT02668653), a randomized, double-blind, placebo-controlled trial of 539 patients where patients received cytarabine with either daunorubicin or idarubicin.