Gilteritinib

Pregnancy
categoryRoutes of
administrationBy mouthATC codeLegal statusLegal status IdentifiersCAS NumberPubChem CIDDrugBankChemSpiderUNIIKEGGChEBIChemical and physical dataFormulaC₂₉H₄₄N₈O₃Molar mass552.724 g·mol⁻¹3D model (JSmol)

Gilteritinib, sold under the brand name Xospata, is an anti-cancer drug.^[7] It acts as an inhibitor of FLT3, hence it is a tyrosine kinase inhibitor.^[8]

It was developed by Astellas Pharma.

In April 2018, Astellas filed a new drug application with the Food and Drug Administration for gilteritinib for the treatment of adult patients with FLT3 mutation–positive relapsed or refractory acute myeloid leukemia (AML).^[9]

In November 2018, the FDA approved gilteritinib for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.^[10][5]

Gilteritinib was granted orphan drug status by the U.S. FDA, the European Commission (EC) and the Japan Ministry of Health, Labor and Welfare, for some AML patients.^[11]

Gilteritinib was approved for medical use in Australia in March 2020.^[12]

References

Further reading

• AusPAR: Gilteritinib (as fumarate). Therapeutic Goods Administration (TGA) (Report). September 2020.

External links

• "Gilteritinib". Drug Information Portal. U.S. National Library of Medicine.
• "Gilteritinib fumarate". NCI Drug Dictionary. National Cancer Institute.
• "Gilteritinib fumarate". National Cancer Institute. 17 January 2019.