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 Mutation Testing at Relapse or Progression Can Inform Your Treatment Decisions1

FLT3 mutation status can change over the course of AML treatment2

The development of FLT3-ITD mutations has been strongly correlated with disease progression and worse prognosis.3


In a retrospective study of 324 patients with AML, a new FLT3-ITD mutation was identified at time of relapse in 10% of the 77 patients who were FLT3-ITD negative at initial diagnosis and subsequently experienced relapse.2


In another retrospective analysis of patients with FLT3m+ AML, among patients with a FLT3-ITD mutation alone who were treated with a FLT3 inhibitor (n=60), 25% (n=15) had both FLT3-ITD and -TKD mutations at the end of treatment.4

A PCR* Test SUCH AS LEUKOSTRAT® CDx FLT3 MUTATION ASSAY is an Effective Way to Identify FLT3 Mutations5

PCR tests have a turnaround time of 2 to 3 business days.5

PCR is a diagnostic tool that may be used to identify FLT3 mutations in AML
Turnaround time5
2-3 business days
Can detect FLT3-ITD 5 Yes
Can detect FLT3-TKD 5 Yes
Can detect emergence of new mutations at relapse3 Yes

*LeukoStrat CDx FLT3 Mutation Assay is the only FDA-approved test for FLT3 mutations and the only approved companion diagnostic to XOSPATA.5,7

Due to poor outcomes associated with FLT3-ITD mutations in AML, confirming FLT3 mutation status at relapse or progression can inform a targeted treatment strategy1-3,8

AML=acute myeloid leukemia; CDx=companion diagnostic; FDA=Food and Drug Administration; FLT3=FMS-like tyrosine kinase 3; ITD=internal tandem duplication; m+=mutation-positive; PCR=polymerase chain reaction; TKD=tyrosine kinase domain.

References: 1. 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. 2. Nazha A, Cortes J, Faderl S, et al. Activating internal tandem duplication mutations of the fms-like tyrosine kinase-3 (FLT3-ITD) at complete response and relapse in patients with acute myeloid leukemia. Haematologica 2012;97(8):1242-5. 3. Warren M, Luthra R, Yin CC, et al. Clinical impact of change of FLT3 mutation status in acute myeloid leukemia patients. Mod Pathol 2012;25(10):1405-12. 4. Alvarado Y, Kantarjian HM, Luthra R, et al. Treatment with FLT3 inhibitor in patients with FLT3-mutated acute myeloid leukemia is associated with development of secondary FLT3-tyrosine kinase domain mutations. Cancer 2014;120(14):2142-9. 5. Invivoscribe. LeukoStrat® CDx FLT3 mutation assay. Accessed 10-21-2021. 6. Patnaik MM. The importance of FLT3 mutational analysis in acute myeloid leukemia. Leuk Lymphoma 2018;59(10):2273-86. 7. US Food and Drug Administration. List of cleared or approved companion diagnostic devices (in vitro and imaging tools) (10-25-2021). Accessed 10-30-2021. 8. McCormick SR, McCormick MJ, Grutkoski PS, et al. FLT3 mutations at diagnosis and relapse in acute myeloid leukemia: cytogenetic and pathologic correlations, including cuplike blast morphology. Arch Pathol Lab Med 2010;134(8):1143-51.