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A single pill that beats salvage chemotherapy for relapsed FLT3-mutated AML, and the backbone of the triplets now being tested in frontline disease.
ADMIRAL (n=371): gilteritinib vs salvage chemotherapy in relapsed/refractory FLT3-mutated AML, OS 9.3 vs 5.6 months (HR 0.64), CR/CRh 34%. Approved 2018. Post-transplant maintenance (MORPHO) reduced relapse in MRD-positive patients. Frontline triplets (gilteritinib + azacitidine + venetoclax) show high CR rates in unfit patients; the phase 3 vs midostaurin (HOVON 156 AML) reported non-superiority for EFS in 2025-26 data, keeping midostaurin/quizartinib as intensive standards.
Type I FLT3/AXL inhibitor active against ITD and TKD (D835) mutations. Connects to FLT3.
1.Gilteritinib binds active FLT3 regardless of ITD or TKD mutation
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).
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 mutation 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 TA642 · SMC advice: gilteritinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
ADMIRAL interim; full OS data 2019
| Region | Year | Indication |
|---|---|---|
| US | 2018 | Relapsed or refractory FLT3-mutated AML |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Differentiation syndrome | 3% | - |
| Transaminase elevation | 44% | - |
| Myalgia/arthralgia | 42% | - |
| Febrile neutropenia | - | 46% |
Boxed warning. Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
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Post-transplant FLT3 inhibitor maintenance helps patients with detectable FLT3-ITD residual disease and can probably be spared in those without it; guidelines now describe maintenance for MRD-positive disease on this evidence.
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:"Gilteritinib" OR ABSTRACT:"Gilteritinib" OR TITLE:"Xospata" OR ABSTRACT:"Xospata") 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 Gilteritinib, 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), 7+3 induction chemotherapy, FLT3 inhibitor + intensive chemotherapy.
Shares FLT3 inhibitor + intensive chemotherapy, QuANTUM-First: quizartinib added to intensive chemotherapy and continued as maintenance in newly diagnosed FLT3-ITD AML, FLT3, FLT3-mutated acute myeloid leukaemia.
Shares ADMIRAL, ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia, FLT3, Acute myeloid leukaemia.
Shares 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, Secondary and therapy-related acute myeloid leukaemia.
Shares FLT3-ITD (internal tandem duplication), FLT3, FLT3-mutated acute myeloid leukaemia, Acute myeloid leukaemia.
Shares A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations, Secondary and therapy-related acute myeloid leukaemia, Acute myeloid leukaemia in children, Acute myeloid leukaemia in older or unfit patients.
Shares Eunice S. Wang, Differentiation syndrome, Acute myeloid leukaemia (KEGG map), Secondary and therapy-related acute myeloid leukaemia.