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Quizartinib is a more selective FLT3 blocker that, added to chemotherapy, roughly doubled median survival in the highest-risk FLT3 subtype.
QuANTUM-First (n=539, FLT3-ITD, age 18-75): median OS 31.9 vs 15.1 months (HR 0.776), including patients not transplanted; benefit sustained in the maintenance phase analysis. Approved July 2023 with a boxed warning for QT prolongation and a REMS. Earlier rejected (2019) in the relapsed setting after QuANTUM-R despite a positive OS result. Approved in Japan 2019.
Type II FLT3 inhibitor binding the inactive DFG-out conformation; potent against ITD, inactive against TKD resistance mutations (D835). Connects to FLT3.
1.Quizartinib locks FLT3-ITD in its inactive conformation
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). REMS-restricted for QT prolongation.
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. FLT3-ITD by an approved test.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA1013. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Complete response letter for relapsed/refractory indication (QuANTUM-R)
Frontline FLT3-ITD AML (QuANTUM-First)
| Region | Year | Indication |
|---|---|---|
| US | 2023 | Newly diagnosed FLT3-ITD AML with 7+3, consolidation, and maintenance |
| Japan | 2019 | Relapsed/refractory FLT3-ITD AML |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| QT prolongation Boxed warning; grade 3 QTc >500 ms in ~3% | - | - |
| Febrile neutropenia | - | 43% |
| Neutropenia Prolonged count recovery during consolidation | - | 20% |
| Hypokalaemia | 32% | - |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
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QuANTUM-First gave FLT3-ITD AML patients a second front-line targeted option and showed that continuing a FLT3 inhibitor as long-term maintenance, including after transplant, pays off. Quizartinib was approved for this indication in 2023. Head-to-head data against midostaurin are lacking, and the design leaves open how much of the benefit came from maintenance.
ADMIRAL showed that a targeted oral drug can beat chemotherapy outright in relapsed AML, and made gilteritinib the standard bridge to transplant for FLT3-mutated relapse. Its success also underpinned FLT3 inhibitor use in first-line combinations. Resistance through FLT3-independent clones and RAS pathway mutations limits durability without transplant.
Query for this drug: (TITLE:"Quizartinib" OR ABSTRACT:"Quizartinib" OR TITLE:"Vanflyta" OR ABSTRACT:"Vanflyta") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Quizartinib, not a curated reading list.
Shares FLT3-TKD (D835 and I836 tyrosine kinase domain mutations), FLT3-ITD (internal tandem duplication), FLT3 inhibitor + intensive chemotherapy, ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia.
Shares FLT3-TKD (D835 and I836 tyrosine kinase domain mutations), FLT3-ITD (internal tandem duplication), FLT3 inhibitor + intensive chemotherapy, ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia.
Shares QuANTUM-First, QuANTUM-First: quizartinib added to intensive chemotherapy and continued as maintenance in newly diagnosed FLT3-ITD AML, FLT3, Acute myeloid leukaemia.
Shares ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia, FLT3, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares QuANTUM-First, FLT3 inhibitor + intensive chemotherapy, QuANTUM-First: quizartinib added to intensive chemotherapy and continued as maintenance in newly diagnosed FLT3-ITD AML, FLT3-mutated acute myeloid leukaemia.
Shares FLT3-ITD (internal tandem duplication), FLT3, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia, FLT3, Acute myeloid leukaemia, Small-molecule kinase inhibitors.
Shares FLT3 inhibitor + intensive chemotherapy, FLT3, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.