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| Trade names | Xospata |
| AHFS/Drugs.com | Monograph |
| MedlinePlus | a619003 |
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| Routes of administration | By mouth |
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| Formula | C29H44N8O3 |
| Molar mass | 552.724 g·mol−1 |
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Gilteritinib, sold under the brand name Xospata, is an anti-cancer drug.[7] It acts as an inhibitorofFLT3, hence it is a tyrosine kinase inhibitor.[8]
It was developedbyAstellas 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 (both ITD and TKD[9]) relapsed or refractory acute myeloid leukemia (AML).[10]
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.[11][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.[12]
Gilteritinib was approved for medical use in Australia in March 2020.[13]
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