The FLT3-ITD mutation—making an already difficult disease even more challenging1

A malignant disease, AML results from the abnormal proliferation and differentiation of myeloid stem cells
in the bone marrow2

  • AML is one of the most common forms of leukemia
    in adults
  • In AML, there are many mutations, but one of the most common is the FLT3 mutation, which includes ITD and TKD3
1 in 3

Among patients with diagnosed AML and identified mutations, approximately 1 in 3 may have a FLT3 mutation3

The FLT3-ITD mutation is associated with disease progression in AML1

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The FLT3 mutation includes ITD and TKD, with ITD occurring the most frequently3

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AML with FLT3-ITD mutations (without adverse-risk genetic lesions) is categorized as intermediate risk and is associated with poor prognosis1,4

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FLT3-ITD mutations activate FLT3 kinase activity, resulting in proliferation and survival of myeloblasts in AML1

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The unregulated proliferation of these cells, as well as their increased survival and lack of differentiation, may contribute to the development of AML2

The FLT3-ITD mutation adversely impacts outcomes in patients with AML compared to those without the mutation1

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Shorter overall survival5

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Increased risk of relapse5

About 75% of patients with FLT3-ITD+ AML at the time of diagnosis continue to have the ITD mutation at relapse, suggesting that FLT3-ITD is associated with disease progression.1

FLT3-ITD is a driver mutation with a high leukemic burden1

~80%

of all FLT3 mutations are ITD+3

In the United States, there are over 70,000 people living with AML, with more than 20,000 new cases estimated in 2025.6,7

OVER 10 YEARS, PATIENTS WITH FLT3-ITD MUTATIONS WERE

~50%

LESS LIKELY TO SURVIVE

COMPARED TO PATIENTS WITH FLT3-TKD MUTATIONS8

From a 2007 retrospective analysis of 1,107 adult patients with AML from the United Kingdom with a median age of 42 years, OS at 10 years in patients with FLT3-ITD and FLT3-TKD was 24% (n=257) and 51% (n=100), respectively (OR: 0.53 [95% CI: 0.41-0.69]; P<0.001, based on log-rank test).8

AML with FLT3-ITD mutations is categorized as intermediate risk.4

  • In fact, FLT3-ITD mutations were the primary predictor of outcome in patients with intermediate-risk AML1,9
  • Patients who received mutation-specific treatment had a higher rate of overall survival compared to standard therapy10

PATIENTS WITH FLT3-ITD MUTATIONS (n=120) WERE

3.4x

MORE LIKELY TO RELAPSE

THAN THOSE WITHOUT FLT3-ITD MUTATIONS (n=86) (HR: 3.4 [95% CI: 1.46-7.94; P=0.005])11

Although the presence of FLT3-ITD is correlated with a higher risk of relapse in the context of allogeneic transplant, the 2-year leukemia-free survival and relapse risk observed for allogeneic HSCT favorably compared with outcomes reported after post-remission chemotherapy only.

A different study from 2012 analyzed 206 adult patients (18 years or older) with de novo AML and normal cytogenetics who underwent myeloablative allogeneic HSCT in CR1 and had FLT3-ITD analysis available at diagnosis. Data from 2000 to 2008 were obtained from the European Group for Blood and Marrow Transplantation. The purpose of the study was to analyze the impact of FLT3-ITD on outcomes in normal cytogenetic AML patients who received allogeneic HSCT.11

Guidelines support prompt and comprehensive FLT3 mutation testing for all patients with AML1,4

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Adult patients with confirmed or suspected AML should be tested for the FLT3-ITD mutation12

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Molecular and cytogenetic analyses are important in helping to identify the appropriate treatment options4

An FDA-approved clinical study assay, such as LeukoStrat® CDx FLT3 Mutation Assay, is a direct way to identify FLT3-ITD mutations.4,12

The LeukoStrat® CDx FLT3 Mutation Assay has a turnaround time of 2-3 business days.13

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Know the FLT3 mutation status. Know the risk.
ACT NOW.

The evolving treatment landscape of FLT3-ITD+ AML

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Intensive induction chemotherapy: the standard of care for fit patients14,15

  • Chemotherapy remains the first-line approach for patients with FLT3-ITD+ AML who are candidates for intensive treatment. Standard care typically includes cytarabine and an anthracycline-based induction (either daunorubicin or idarubicin) chemotherapy (7+3), now often recommended to be administered in combination with targeted therapies such as FLT3 inhibitors
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Allogeneic HSCT for consolidation: the gold standard curative treatment option in AML1,15-18

  • For patients who achieve remission following induction, allogenic HSCT is the preferred consolidation strategy for those with FLT3-ITD mutations who are at a higher risk of relapse. Allogeneic HSCT remains the most effective curative-intent therapy for eligible patients. Other recommended treatment options for consolidation include standard cytarabine chemotherapy in combination with targeted therapies such as FLT3 inhibitors
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Up to 60% of patients with AML may not receive a transplant4,19

  • In patients <70 years of age in the United States and Canada in 2016, based on a retrospective global AML incidence report study analyzing data from 2009 to 2016
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Potential barriers to receiving transplant20,21

  • Age
  • Comorbidities
  • Donor availability
  • Financial burden
  • Logistical barriers
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Maintenance therapy: potential role in post-consolidation care4,15

  • In the post-consolidation setting, maintenance therapy is increasingly recognized as a strategy to reduce relapse risk in patients with FLT3-ITD+ AML. Current treatment guidelines recommend chemotherapy or targeted therapy based on previous treatment with chemotherapy or allogeneic HSCT

VANFLYTA is not indicated as maintenance monotherapy following allogeneic HSCT; improvement in overall survival with VANFLYTA in this setting has not been demonstrated.

Consider a targeted FLT3 inhibitor as part of a treatment
approach to managing FLT3-ITD+ AML

EXPLORE EFFICACY
DATA NOW
SEE VANFLYTA
SAFETY DATA

AML=acute myeloid leukemia; CI=confidence interval; CR1=first complete remission; FLT3=FMS (feline McDonough sarcoma)–like tyrosine kinase 3; HR=hazard ratio; HSCT=hematopoietic stem cell transplantation; ITD=internal tandem duplication; NCCN=National Comprehensive Cancer Network® (NCCN®); OR=odds ratio; OS=overall survival; REMS=Risk Evaluation and Mitigation Strategy; TKD=tyrosine kinase domain.

References:

1. Daver N, Schlenk RF, Russell NH, Levis MJ. Targeting FLT3 mutations in AML: review of current knowledge and evidence. Leukemia. 2019;33:299-312. doi:10.1038/s41375-018-0357-9 2. Vakiti A, Reynolds SB, Mewawalla P. Acute Myeloid Leukemia. In: StatPearls. NCBI Bookshelf. Updated April 27, 2024. Accessed September 8, 2025. https://www.ncbi.nlm.nih.gov/books/NBK507875/ 3. Patel PJ, Gönen M, Figueroa ME, et al. Prognostic relevance of integrated genetic profiling in acute myeloid leukemia. N Engl J Med. 2012;366(12):1079-1089. doi:10.1056/NEJMoa1112304 4. Döhner H, Wei AH, Appelbaum FR, et al. Diagnosis and management of AML in adults: 2022 recommendations from an international expert panel on behalf of the ELN. Blood. 2022;140(12):1345-1377. doi:10.1182/blood.2022016867 5. Erba HP, Montesinos P, Kim HJ, et al. Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. Published online: April 25, 2023. doi:10.1016/S0140-6736(23)00464-6 6. National Cancer Institute. Cancer stat facts: leukemia—acute myeloid leukemia (AML). Accessed May 29, 2025. https://seer.cancer.gov/statfacts/html/amyl.html 7. Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025;75(1):10-45. doi:10.3322/caac.21871 8. Mead AJ, Linch DC, Hills RK, Wheatley K, Burnett AK, Gale RE. FLT3 tyrosine kinase domain mutations are biologically distinct from and have a significantly more favorable prognosis than FLT3 internal tandem duplications in patients with acute myeloid leukemia. Blood. 2007;110(4):1262-1270. doi:10.1182/blood-2006-04-015826 9. Gale RE, Green C, Allen C, et al. The impact of FLT3 internal tandem duplication mutant level, number, size, and interaction with NPM1 mutations in a large cohort of young adult patients with acute myeloid leukemia. Blood. 2008;111(5):2776-2784. doi:10.1182/blood-2007-08-109090 10. Burd A, Levine RL, Ruppert AS, et al. Precision medicine treatment in acute myeloid leukemia using prospective genomic profiling: feasibility and preliminary efficacy of the Beat AML Master Trial. Nat Med. 2020;26(12):1852-1858. doi:10.1038/s41591-020-1089-8 11. Brunet S, Labopin M, Esteve J, et al. Impact of FLT3 internal tandem duplication on the outcome of related and unrelated hematopoietic transplantation for adult acute myeloid leukemia in first remission: a retrospective analysis. J Clin Oncol. 2012;30(7):735-741. doi:10.1200/JCO.2011.36.9868 12. Arber DA, Borowitz MJ, Cessna M, et al. Initial diagnostic workup of acute leukemia: guideline from the College of American Pathologists and the American Society of Hematology. Arch Pathol Lab Med. 2017;141(10):1342-1393. doi:10.5858/arpa.2016-0504-CP 13. LeukoStrat® CDx FLT3 Mutation Assay. San Diego, CA: lnvivoscribe. Inc: 2017. Accessed August 31, 2023. https://invivoscribe.com/uploads/products/informationalDownloads/La bPMM-Flyer_Leukostrat CDx_FLT3 _8.5x1L20170420.pdf 14. Zhang Z, Huang J, Zhang Z, et al. Application of omics in the diagnosis, prognosis, and treatment of acute myeloid leukemia. Biomark Res. 2024;12(1):60. doi:10.1186/s40364-024-00600-1 15. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.2.2026. © National Comprehensive Cancer Network, Inc. 2025. All rights reserved. Accessed October 3, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org 16. Loke J, Buka R, Craddock C. Allogeneic stem cell transplantation for acute myeloid leukemia: who, when, and how? Front Immunol. 2021;12:659595. doi:10.3389/fimmu.2021.659595 17. DeWolf S, Tallman MS, Rowe JM, Salman MY. What influences the decision to proceed to transplant for patients with AML in first remission? J Clin Oncol. 2023;41(29):4693-4703. doi:10.1200/JCO.22.02868 18. Armenian SH, Chen Y, Hageman L, et al. Burden of long-term morbidity borne by survivors of acute myeloid leukemia treated with blood or marrow transplantation: the results of the BMT Survivor Study. J Clin Oncol. 2022;40(28):3278-3288. doi:10.1200/JCO.21.02829 19. Tokaz MC, Baldomero H, Cowan AJ, et al. An analysis of the worldwide utilization of hematopoietic stem cell transplantation for acute myeloid leukemia. Transplant Cell Ther. 2023;29(4):279.e1-279.e10. doi:10.1016/j.jtct.2022.12.013 20. Flannelly C, E-Xin Tan B, Tan JL, et al. Barriers to hematopoietic cell transplantation for adults in the United States: a systematic review with a focus on age. Biol Blood Marrow Trans. 2020;26(12):2335-2345. doi:10.1016/j.bbmt.2020.09.013 21. Hong S, Majhail NS. Increasing access to allotransplants in the United States: the impact of race, geography, and socioeconomics. Hematology Am Soc Hematol Educ Program. 2021;(1):275-280. https://doi.org.10.1182/hematology.2021000259