Gilteritinib
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.
1.Gilteritinib binds active FLT3 regardless of ITD or TKD mutation
- Route
- Oral
- Schedule
- 120 mg once daily until progression or unacceptable toxicity (minimum 6 months to allow response)
- Monitoring
- Differentiation syndrome (boxed warning), QT, LFTs, PRES, pancreatitis
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part D (self-administered)
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).
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Astellas Pharma Support Solutions
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- Appraised for
- Relapsed or refractory FLT3 mutation-positive AML
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA642 · SMC advice: gilteritinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 28 Nov 2018ApprovalUS
ADMIRAL interim; full OS data 2019
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
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.
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductMidostaurin
Shares 7+3 induction chemotherapy, FLT3 inhibitor + intensive chemotherapy, ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia, QuANTUM-First: quizartinib added to intensive chemotherapy and continued as maintenance in newly diagnosed FLT3-ITD AML.
- ProductQuizartinib
Shares FLT3 inhibitor + intensive chemotherapy, ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia, QuANTUM-First: quizartinib added to intensive chemotherapy and continued as maintenance in newly diagnosed FLT3-ITD AML, FLT3.
- TrialQuANTUM-First
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Shares FLT3 inhibitor + intensive chemotherapy, FLT3, Acute myeloid leukaemia, Small-molecule kinase inhibitors.
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Shares FLT3 inhibitor + intensive chemotherapy, QuANTUM-First: quizartinib added to intensive chemotherapy and continued as maintenance in newly diagnosed FLT3-ITD AML, Acute myeloid leukaemia.
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Shares Eunice S. Wang, Differentiation syndrome, Acute myeloid leukaemia.
- TermFLT3-ITD allelic ratio
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