VANFLYTA (quizartinib) is an orally administered kinase inhibitor. It functions by targeting and inhibiting the FLT3 (FMS-like tyrosine kinase 3) receptor tyrosine kinase. Specifically, quizartinib and its major active metabolite, AC886, bind to the ATP binding domain of FLT3, including the FLT3-ITD mutation, thereby preventing receptor autophosphorylation. This action interrupts downstream FLT3 receptor signaling pathways, which are crucial for the proliferation of FLT3-ITD-dependent leukemic cells, ultimately leading to an anti-tumor effect in this specific AML subtype.

VANFLYTA is prescribed for adult patients newly diagnosed with FLT3-ITD-positive AML, integrated into a multi-phase treatment regimen including induction, consolidation, and maintenance therapy. Due to significant safety concerns, notably the risk of QT interval prolongation, Torsades de Pointes, and cardiac arrest, VANFLYTA is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS). It is supplied as film-coated tablets in strengths of 17.7 mg and 26.5 mg of quizartinib. Careful cardiac monitoring and electrolyte management are imperative throughout treatment.