Quizartinib

1 Indications and usage vanflyta: is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as 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 .

12.1 Mechanism of Action Quizartinib is a small molecule inhibitor of the receptor tyrosine kinase FLT3. Quizartinib and its major active metabolite AC886 bind to the adenosine triphosphate (ATP) binding domain of FLT3 with comparable affinity, and both had 10-fold lower affinity towards FLT3-ITD mutation compared to FLT3 in a binding assay. Quizartinib and AC886 inhibited FLT3 kinase activity, preventing autophosphorylation of the receptor, thereby inhibiting downstream FLT3 receptor signaling and blocking FLT3-ITD-dependent cell proliferation. Quizartinib showed antitumor activity in a mouse model of FLT3-ITD-dependent leukemia.

Following administration (26.5 mg/1 Tablet, Film Coated), Quizartinib achieves Estimated 48%–60% oral systemic absorption for Quizartinib bioavailability and peak plasma concentration (tmax) reached 1–2 hours post-dose for quizartinib onset, governed by a Approximately 3–9 hours terminal plasma half-life for Quizartinib terminal half-life through phase i/ii hepatic conjugation of quizartinib coupled with glomerular and tubular renal excretion.

Before initiating Quizartinib at 26.5 mg/1 Tablet, Film Coated, clinical safety checklists rule out severe drug-induced hypersensitivity to quizartinib or inactive tablet/vehicle binders; prohibited co-prescriptions or physiological states specified in fda spl 2026-04-16 for quizartinib. Logged tolerability patterns center on nausea (10.8% of reports), headache (9.4% of reports), diarrhea (8.1% of reports).