# Gilteritinib

Source: https://onco.cc/drugs/gilteritinib/  
OnCo record `gilteritinib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A single pill that beats salvage chemotherapy for relapsed FLT3-mutated AML, and the backbone of the triplets now being tested in frontline disease.

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Xospata
- Modality: Small-molecule kinase inhibitor (FLT3, type I)
- Mechanism: Type I FLT3/AXL inhibitor active against ITD and TKD (D835) mutations.
- Approvals: US 2018: Relapsed or refractory FLT3-mutated AML
- Dosing: Oral; 120 mg once daily until progression or unacceptable toxicity (minimum 6 months to allow response)
- Toxicity (grade 3+): Febrile neutropenia 46%

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Gilteritinib
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Gilteritinib

## Connected records

- biomarkers: [FLT3-ITD (internal tandem duplication)](https://onco.cc/biomarkers/flt3-itd/), [FLT3-TKD (D835 and I836 tyrosine kinase domain mutations)](https://onco.cc/biomarkers/flt3-tkd/)
- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/), [Acute myeloid leukaemia in children](https://onco.cc/cancers/aml-paediatric/), [Acute myeloid leukaemia in older or unfit patients](https://onco.cc/cancers/aml-older-unfit/), [FLT3-mutated acute myeloid leukaemia](https://onco.cc/cancers/aml-flt3/), [Secondary and therapy-related acute myeloid leukaemia](https://onco.cc/cancers/aml-secondary/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [FLT3](https://onco.cc/targets/flt3/), [STAT5 (STAT5A, STAT5B)](https://onco.cc/targets/stat5/)
- companies: [Astellas](https://onco.cc/companies/astellas/)
- terms: [7+3 induction chemotherapy](https://onco.cc/terms/seven-plus-three/), [Differentiation syndrome](https://onco.cc/terms/differentiation-syndrome/)
- trials: [A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)](https://onco.cc/trials/nct04988555/), [A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation](https://onco.cc/trials/nct03182244/), [A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia](https://onco.cc/trials/nct05520567/), [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](https://onco.cc/trials/nct04293562/), [ADMIRAL](https://onco.cc/trials/admiral/), [Beat AML Master Trial](https://onco.cc/trials/beat-aml-master-trial/), [MORPHO](https://onco.cc/trials/morpho/)
- pairings: [FLT3 inhibitor + intensive chemotherapy](https://onco.cc/pairings/flt3i-plus-7-3/)
- people: [Eunice S. Wang](https://onco.cc/people/eunice-wang/)
- key papers: [ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia](https://onco.cc/key-papers/paper-admiral-gilteritinib-flt3-nejm-2019/), [MORPHO: gilteritinib as post-transplant maintenance for FLT3-ITD acute myeloid leukaemia](https://onco.cc/key-papers/paper-morpho-gilteritinib-levis-jco-2024/), [QuANTUM-First: quizartinib added to intensive chemotherapy and continued as maintenance in newly diagnosed FLT3-ITD AML](https://onco.cc/key-papers/paper-quantum-first-quizartinib-lancet-2023/)
- pathways: [Acute myeloid leukaemia (KEGG map)](https://onco.cc/pathways/aml-signalling/)

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