NCCN Guidelines®

For eligible patients with newly diagnosed FLT3-ITD+ AML1

The first and only
FLT3 inhibitor to specifically
target the FLT3-ITD mutation—one of the most aggressive threats in AML

VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)–positive as detected by an FDA-approved test.2

Limitations of Use: VANFLYTA is not indicated as maintenance monotherapy following allogeneic hematopoietic stem cell transplantation (HSCT); improvement in overall survival with VANFLYTA in this setting has not been demonstrated.2

QuANTUM-First is a Phase 3, randomized, double-blind, placebo-controlled study of 539 patients, ages 18-75, with newly diagnosed FLT3-ITD+ AML. Patients were randomized to VANFLYTA plus chemotherapy (N=268) or placebo plus chemotherapy (N=271). Primary endpoint was overall survival.2

NCCN Guidelines®
3.5x icon

FLT3-ITD+ AML patients
are 3.5x less likely to survive
compared to patients with a
FLT3-TKD mutation3,4*

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VANFLYTA was studied for
overall survival vs standard
chemotherapy alone

Explore efficacy data now
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VANFLYTA support
and resources

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*Studied comparing 5-year survival rates of patients with TKD mutations (53% OS) vs patients with ITD mutations (15% OS).3,4

AML=acute myeloid leukemia; BM=bone marrow; FLT3=FMS (feline McDonough sarcoma)–like tyrosine kinase 3; HCT=hematopoietic cell transplantation; HiDAC=high-dose cytarabine; ITD=internal tandem duplication; NCCN=National Comprehensive Cancer Network® (NCCN®); OS=overall survival; REMS=Risk Evaluation and Mitigation Strategy; TKD=tyrosine kinase domain.


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. VANFLYTA [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2023. 3. 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 4. 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 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed June 3, 2024. To review the most recent and complete version of the guideline, go to