Gilteritinib

Gilteritinib, sold under the brand name Xospata, is an anti-cancer drug.

Mechanism of action

Gilteritinib acts as an inhibitor of FLT3, hence it is a tyrosine kinase inhibitor.

History

Gilteritinib 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].
In November 2018, the FDA approved gilteritinib for treatment of adult patients with relapsed or refractory acute myeloid leukemia with a FLT3 mutation as detected by an FDA-approved test. It is effective beyound second line of therapy.
Gilteritinib was granted orphan drug status by the U.S. FDA, the European Commission and the Japan Ministry of Health, Labor and Welfare, for some AML patients.
Gilteritinib was approved for medical use in Australia in March 2020.