FDA Approval Summary: Gilteritinib for Relapsed or Refractory Acute Myeloid Leukemia with a <i>FLT3</i> Mutation.

ABSTRACT: On November 28, 2018, the FDA approved gilteritinib (Xospata; Astellas), a small-molecule FMS-like tyrosine kinase 3 (FLT3) inhibitor, for treatment of relapsed or refractory acute myeloid leukemia with a FLT3 mutation as detected by an FDA-approved test. In the ADMIRAL study, patients were randomized 2:1 to receive gilteritinib or standard chemotherapy and stratified by response to first-line treatment and intensity of prespecified chemotherapy. Efficacy was established on interim analysis on the basis of complete remission (CR) + CR with partial hematologic recovery (CRh) rate, duration of CR + CRh, and conversion from transfusion dependence to transfusion independence in 138 patients in the gilteritinib arm. With median follow-up of 4.6 months [95% confidence interval (CI), 2.8-1

SUBMITTER: Pulte ED 

PROVIDER: S-EPMC8506653 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature