Article
FDA Approval Summary: Gilteritinib for Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation.
Clinical cancer research : an official journal of the American Association for Cancer Research - 1 Jul 2021
Pulte E Dianne, Norsworthy Kelly J, Wang Yaping, Xu Qing, Qosa Hisham, Gudi Ramadevi, Przepiorka Donna, Fu Wentao, Okusanya Olanrewaju O, Goldberg Kirsten B, De Claro R Angelo, Farrell Ann T, Pazdur Richard
Abstract excerpt
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...
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