TY - CHAP M1 - Book, Section TI - Acute Leukemias A1 - Seung, Amy Hatfield A1 - Dabb, Alix A2 - DiPiro, Joseph T. A2 - Talbert, Robert L. A2 - Yee, Gary C. A2 - Matzke, Gary R. A2 - Wells, Barbara G. A2 - Posey, L. Michael PY - 2017 T2 - Pharmacotherapy: A Pathophysiologic Approach, 10e AB - Content UpdateNovember 17, 2019Gilteritinib for Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia: In November 2018, the U.S. Food and Drug Administration (FDA) granted approval to gilteritinib (Xospata) for treatment of relapsed or refractory acute myeloid leukemia (AML) with an FLT3 mutation. Gilteritinib is a highly selective FLT3 inhibitor with activity against both types of FLT3 mutations. FDA approval was based on an interim analysis of response rate and duration of response in the gilteritinib arm of the ADMIRAL trial; the results of the phase 3 ADMIRAL trial were recently published. Patients randomized to receive gilteritinib had a higher complete remission rate and longer median overall survival than patients who received salvage chemotherapy. Grade 3 or higher adverse events occurred less frequently in the gilteritinib group. Based on these results, gilteritinib is now an NCCN category 1 therapy for patients with relapsed or refractory AML with FLT3 mutation. SN - PB - McGraw-Hill Education CY - New York, NY Y2 - 2024/04/18 UR - accesspharmacy.mhmedical.com/content.aspx?aid=1167563380 ER -