Description
On November 28, 2018, the Food and Drug Administration approved gilteritinib for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
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. Gilteritinib was approved for medical use in Australia in March 2020.
References:
- FDA approves gilteritinib for relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation
- FDA Approval Summary: Gilteritinib for Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation
- FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation