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Quizartinib
Source: Acute Myeloid Leukemia Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: March 14, 2025 · Captured 2026-09-09.
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Evidence (quizartinib):
A multicenter, randomized, phase III trial (NCT02668653) included patients with FLT3-ITD–altered AML. Patients received either the selective ITD-specific FLT3 inhibitor, quizartinib, or placebo in addition to cytarabine and daunorubicin induction chemotherapy. The addition of quizartinib led to improved survival (median, 31.9 vs. 15.1 months; HR for death, 0.78; P = .032).[16]
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A multicenter, randomized, phase III trial (NCT02668653) included patients with FLT3-ITD–altered AML. Patients received either the selective ITD-specific FLT3 inhibitor, quizartinib, or placebo in addition to cytarabine and daunorubicin induction chemotherapy. The addition of quizartinib led to improved survival (median, 31.9 vs. 15.1 months; HR for death, 0.78; P = .032).[16]
The EFS (defined as the time from randomization to lack of CR within 42 days from the start of the last induction cycle, relapse, or death from any cause, whichever occurred first) was similar for patients in the quizartinib and placebo arms (HR for event or death, 0.92; 95% CI, 0.75–1.11; P = .24). The rates of CR and time to neutrophil count recovery were similar between the two arms.[16][Level of evidence A1]
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The FDA approved quizartinib in combination with induction therapy for patients with AML and an FLT3-ITD variant but not for patients with other FLT3 variants, such as FLT3-TKD.
The addition of an FLT3 inhibitor to induction chemotherapy is the standard of care for patients with FLT3-altered AML who are eligible for intensive chemotherapy. An ongoing study (NCT03836209) is evaluating which FLT3 inhibitor is best for patients with FLT3-ITD AML receiving up-front chemotherapy. Additional studies are evaluating FLT3 inhibitors in combination with hypomethylating agents and venetoclax in patients who are not candidates for intensive therapy.
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Studies cited in this source section
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Preserved source evidence · Not medical advice