Therapeutic Response

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

Statements

Source and description
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.
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. 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.