Gilteritinib (XOSPATA) is the ONLY Category 1 recommendation for patients with relapsed or refractory AML with a FLT3 mutation in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)1

FLT3-ITD Mutations Cut Survival Short in
Relapsed or Refractory FLT3m+ AML1

FLT3 mutations are the most common mutations in AML2

Of patients newly diagnosed with AML and tested for FLT3 mutations:


were positive for FLT3-ITD


were positive for FLT3-TKD

FLT3-ITD mutations negatively impact survival in relapsed or refractory AML1

In a retrospective, multicenter study of 138 adult patients with relapsed (n=81) or refractory (n=57) AML treated with intensive salvage chemotherapy regimens, FLT3-ITD mutations were associated with an adverse impact on OS.

Retest at Relapse

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend testing all AML patients for FLT3 mutations at each relapse or progression3

AML=acute myeloid leukemia; FLT3=FMS-like tyrosine kinase 3; ITD=internal tandem duplication; m+=mutation-positive; NCCN=National Comprehensive Cancer Network; OS=overall survival; TKD=tyrosine kinase domain.

References: 1. Chevallier P, Labopin M, Turlure P, et al. A new Leukemia Prognostic Scoring System for refractory/relapsed adult acute myelogeneous leukaemia patients: a GOELAMS study. Leukemia 2011;25(6):939-44. 2. Patel JP, Gönen M, Figueroa ME, et al. Prognostic relevance of integrated genetic profiling in acute myeloid leukemia. N Engl J Med 2012;366(12):1079-89. 3. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.1.2022. © National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed 12-03-2021. To view the most recent and complete version of the guideline, go online to NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.