A non-CME virtual event sponsored by Daiichi Sankyo Advances in AML Series: Discussion on QuANTUM-First. Hear from top experts in your field.

REGISTER NOW

A non-CME virtual event sponsored by Daiichi Sankyo Advances in AML Series: Discussion on QuANTUM-First. Hear from top experts in your field.

REGISTER NOW

VANFLYTA® (quizartinib) logo
  • This site is intended for US healthcare professionals.
  • VANFLYTA REMS
  • Prescribing Information
  • Important Safety Information
  • Contact A Rep
  • For Patients
  • ABOUT
    FLT3-ITD+ AML
    • FLT3-ITD Mutations in AML
    • FLT3 Mutation Testing
    • Evolving Treatment Landscape
  • ABOUT
    VANFLYTA
    • Mechanism of Action
    • FLT3 Selectivity
  • EFFICACY
    • Study Design
    • Overall Survival
    • CR and CRc
    • Duration of CR
    • RFS
  • SAFETY
    • Common Adverse Reactions
    • VANFLYTA REMS
  • DOSING
    • Dosing Snapshot
    • ECG and Electrolyte Monitoring
    • Administration
    • Titration and Dose Modifications
  • NCCN
    GUIDELINES®
  • RESOURCES
    • Access Central
    • Clinical Resources
    • How to Procure VANFLYTA
VANFLYTA® (quizartinib) logo
  • This site is intended for US healthcare professionals.
  • ABOUT FLT3-ITD+ AML
    • FLT3-ITD Mutations in AML
    • FLT3 Mutation Testing
    • Evolving Treatment Landscape
  • ABOUT VANFLYTA
    • Mechanism of Action
    • FLT3 Selectivity
  • EFFICACY
    • Study Design
    • Overall Survival
    • CR and CRc
    • Duration of CR
    • RFS
  • SAFETY
    • Common Adverse Reactions
    • VANFLYTA REMS
  • DOSING
    • Dosing Snapshot
    • ECG and Electrolyte Monitoring
    • Administration
    • Titration and Dose Modifications
  • NCCN GUIDELINES®
  • RESOURCES
    • Access Central
    • Clinical Resources
    • How to Procure VANFLYTA
  • VANFLYTA REMS
  • Prescribing Information
  • Important Safety Information
  • Contact A Rep
  • For Patients
NCCN Guidelines®

For treatment-eligible patients with
newly diagnosed FLT3-ITD+ AML

Start and stay with VANFLYTA—the only
FLT3 inhibitor FDA-approved for use in
INDUCTION, CONSOLIDATION,
AND MAINTENANCE1-3*

*In patients without prior allogeneic HSCT.
Please see Full Indication, including Limitations of Use, below.

Graphic: FLT3-ITD+, AN AGGRESSIVE THREAT IN AML. FOCUS YOUR ATTACK WITH VANFLYTA (quizartinib
flt3-itd icon

Find out how the FLT3-ITD
mutation affects AML

LEARN ABOUT
THE MUTATION
resources icon

Studied in a wide range of ages,
up to 75 years of age1,5

DISCOVER THE
QuANTUM-FIRST STUDY
efficacy data icon

VANFLYTA showed superior
overall survival vs placebo plus
standard chemotherapy alone1,5†
HR: 0.78; 95% CI: 0.62–0.98;
P=0.0324 †See efficacy section
for additional context.

EXPLORE THE DATA NOW
sign up icon

Enroll today in the VANFLYTA
REMS by completing a one-time
training to prescribe VANFLYTA

ENROLL NOW IN
VANFLYTA REMS
Handshake icon

Connect with a DSI Representative for more information

CONNECT WITH A REP

AML=acute myeloid leukemia; CI=confidence interval; FLT3=FMS (feline McDonough sarcoma)–like tyrosine kinase 3; HR=hazard ratio; HSCT=hematopoietic stem cell transplantation; NCCN=National Comprehensive Cancer Network® (NCCN®); REMS=Risk Evaluation and Mitigation Strategy.

References:

1. VANFLYTA [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc; 2024. 2. XOSPATA [package insert]. Northbrook, IL: Astellas Pharma US, Inc; 2022. 3. RYDAPT [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2023. 4. 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 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

NCCN Guidelines®

Indication and Important Safety Information
Collapse collapse icon Expand expand icon
Indication

VANFLYTA® (quizartinib) 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.

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.

WARNING: QT PROLONGATION, TORSADES DE POINTES, and CARDIAC ARREST

  • VANFLYTA prolongs the QT interval in a dose- and concentration-related manner. Prior to VANFLYTA administration and periodically, monitor for hypokalemia or hypomagnesemia, and correct deficiencies. Perform electrocardiograms (ECGs) to monitor the QTc at baseline, weekly during induction and consolidation therapy, weekly for at least the first month of maintenance, and periodically thereafter.
  • Torsades de pointes and cardiac arrest have occurred in patients receiving VANFLYTA. Do not administer VANFLYTA to patients with severe hypokalemia, severe hypomagnesemia, or long QT syndrome.
  • Do not initiate treatment with VANFLYTA or escalate the VANFLYTA dose if the QT interval corrected by Fridericia’s formula (QTcF) is greater than 450 ms.
  • Monitor ECGs more frequently if concomitant use of drugs known to prolong the QT interval is required.
  • Reduce the VANFLYTA dose when used concomitantly with strong CYP3A inhibitors, as they may increase quizartinib exposure.
  • Because of the risk of QT prolongation, VANFLYTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the VANFLYTA REMS.

WARNING: QT PROLONGATION, TORSADES DE POINTES, and CARDIAC ARREST

  • VANFLYTA® (quizartinib) prolongs the QT interval in a dose- and concentration-related manner. Prior to VANFLYTA administration and periodically, monitor for hypokalemia or hypomagnesemia, and correct deficiencies. Perform electrocardiograms (ECGs) to monitor the QTc at baseline, weekly during induction and consolidation therapy, weekly for at least the first month of maintenance, and periodically thereafter.
  • Torsades de pointes and cardiac arrest have occurred in patients receiving VANFLYTA. Do not administer VANFLYTA to patients with severe hypokalemia, severe hypomagnesemia, or long QT syndrome.
  • Do not initiate treatment with VANFLYTA or escalate the VANFLYTA dose if the QT interval corrected by Fridericia’s formula (QTcF) is greater than 450 ms.
  • Monitor ECGs more frequently if concomitant use of drugs known to prolong the QT interval is required.
  • Reduce the VANFLYTA dose when used concomitantly with strong CYP3A inhibitors, as they may increase quizartinib exposure.
  • Because of the risk of QT prolongation, VANFLYTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the VANFLYTA REMS.

Contraindications

  • VANFLYTA is contraindicated in patients with severe hypokalemia, severe hypomagnesemia, long QT syndrome, or in patients with a history of ventricular arrhythmias or torsades de pointes.

Warnings and Precautions

QT Prolongation, Torsades de Pointes, and Cardiac Arrest (See BOXED WARNING)

  • VANFLYTA prolongs the QT interval in a dose- and concentration-dependent manner. The mechanism of QTc interval prolongation is via inhibition of the slow delayed rectifier potassium current, IKs, as compared to all other medications that prolong the QTc interval, which is via the rapid delayed rectifier potassium current, IKr.
  • The level of QTc prolongation with VANFLYTA that predicts the risk of cardiac arrhythmias is unclear. Inhibition of IKs and IKr may leave patients with limited reserve, leading to a higher risk of QT prolongation and serious cardiac arrhythmias, including fatal outcomes. Torsades de pointes, ventricular fibrillation, cardiac arrest, and sudden death have occurred in patients treated with VANFLYTA.
  • Among 1,081 VANFLYTA-treated AML patients in clinical trials, severe cardiac arrhythmias occurred primarily during induction and included torsades de pointes (0.2%), cardiac arrest (0.6%, including 0.4% fatal), and ventricular fibrillation (0.1%).
  • Of the 265 patients who received VANFLYTA in the clinical trial, 2.3% had a QTcF >500 ms and 10% had an increase of >60 ms from baseline. The trial excluded patients with a QTcF ≥450 ms or other factors that increased the risk of QT prolongation or arrhythmic events (eg, NYHA Class III/IV congestive heart failure, hypokalemia, or a family history of long QT interval syndrome).
  • Avoid use in patients who are at significant risk of developing torsades de pointes, including uncontrolled or significant cardiac disease, recent myocardial infarction, heart failure, unstable angina, bradyarrhythmias, tachyarrhythmias, uncontrolled hypertension, high-degree atrioventricular block, severe aortic stenosis, or uncontrolled hypothyroidism.
  • During induction and consolidation, perform an ECG prior to initiation and then once weekly during VANFLYTA treatment or more frequently as clinically indicated. During maintenance, perform ECGs prior to initiation, once weekly for at least the first month following dose initiation and escalation, and as clinically indicated thereafter.
  • Perform ECG monitoring of the QT interval more frequently in patients who are at significant risk of developing QT interval prolongation and torsades de pointes, or following dose escalation.
  • Monitor and correct hypokalemia and hypomagnesemia prior to and during treatment. Maintain electrolytes in the normal range. Monitor electrolytes and ECGs more frequently in patients who experience diarrhea or vomiting.
  • Reduce the VANFLYTA dose if QTc increases to greater than 480 ms and less than 500 ms. Interrupt and reduce the VANFLYTA dose if QTc increases to greater than 500 ms. Permanently discontinue VANFLYTA in patients who develop recurrent QTc greater than 500 ms or QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.

VANFLYTA REMS

  • Requirements include:
    • Prescribers must be certified in the VANFLYTA REMS by enrolling and completing training.
    • Prescribers must counsel patients receiving VANFLYTA about the risk of QT prolongation, torsades de pointes, and cardiac arrest, and provide patients with a Patient Wallet Card.
    • Pharmacies that dispense VANFLYTA must be certified with the VANFLYTA REMS and must verify prescribers are certified through the VANFLYTA REMS.
  • Further information is available at www.VANFLYTAREMS.com or by telephone at 1-855-212-6670.

Embryo-Fetal Toxicity

  • Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with VANFLYTA and for 7 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with VANFLYTA and for 4 months after the last dose.

Adverse Reactions

  • The most common (>20%) adverse reactions, including laboratory abnormalities, were lymphocytes decreased (60%), potassium decreased (59%), albumin decreased (53%), phosphorus decreased (52%), alkaline phosphatase increased (51%), magnesium decreased (44%), febrile neutropenia (44%), diarrhea (42%), mucositis (38%), nausea (34%), calcium decreased (33%), abdominal pain (30%), sepsis (30%), neutropenia (29%), headache (28%), creatine phosphokinase increased (26%), vomiting (25%), and upper respiratory tract infection (21%).

Drug Interactions

  • Strong CYP3A Inhibitors: Reduce the VANFLYTA dose due to increased quizartinib concentrations.
  • Strong or Moderate CYP3A Inducers: Avoid concomitant use due to decreased quizartinib concentrations.

Use in Specific Populations

  • Advise women not to breastfeed during treatment with VANFLYTA and for one month after the last dose.

To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc., at 1-877-437-7763 or the FDA at 1-800-FDA-1088 or fda.gov/medwatch.


Indication

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.

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.

Please see Full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

Indication and Important Safety Information
Collapse collapse icon Expand expand icon
Indication

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.

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.

WARNING: QT 3 PROLONGATION, TORSADES DE POINTES, and CARDIAC ARREST

  • VANFLYTA prolongs the QT interval in a dose- and concentration-related manner. Prior to VANFLYTA administration and periodically, monitor for hypokalemia or hypomagnesemia, and correct deficiencies. Perform electrocardiograms (ECGs) to monitor the QTc at baseline, weekly during induction and consolidation therapy, weekly for at least the first month of maintenance, and periodically thereafter.
  • Torsades de pointes and cardiac arrest have occurred in patients receiving VANFLYTA. Do not administer VANFLYTA to patients with severe hypokalemia, severe hypomagnesemia, or long QT syndrome.
  • Do not initiate treatment with VANFLYTA or escalate the VANFLYTA dose if the QT interval corrected by Fridericia’s formula (QTcF) is greater than 450 ms.
  • Monitor ECGs more frequently if concomitant use of drugs known to prolong the QT interval is required.
  • Reduce the VANFLYTA dose when used concomitantly with strong CYP3A inhibitors, as they may increase quizartinib exposure.
  • Because of the risk of QT prolongation, VANFLYTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the VANFLYTA REMS.

Contraindications

  • VANFLYTA is contraindicated in patients with severe hypokalemia, severe hypomagnesemia, long QT syndrome, or in patients with a history of ventricular arrhythmias or torsades de pointes.

Warnings and Precautions

QT Prolongation, Torsades de Pointes, and Cardiac Arrest (See BOXED WARNING)

  • VANFLYTA prolongs the QT interval in a dose- and concentration-dependent manner. The mechanism of QTc interval prolongation is via inhibition of the slow delayed rectifier potassium current, IKs, as compared to all other medications that prolong the QTc interval, which is via the rapid delayed rectifier potassium current, IKr.
  • The level of QTc prolongation with VANFLYTA that predicts the risk of cardiac arrhythmias is unclear. Inhibition of IKs and IKr may leave patients with limited reserve, leading to a higher risk of QT prolongation and serious cardiac arrhythmias, including fatal outcomes. Torsades de pointes, ventricular fibrillation, cardiac arrest, and sudden death have occurred in patients treated with VANFLYTA.
  • Among 1,081 VANFLYTA-treated AML patients in clinical trials, severe cardiac arrhythmias occurred primarily during induction and included torsades de pointes (0.2%), cardiac arrest (0.6%, including 0.4% fatal), and ventricular fibrillation (0.1%).
  • Of the 265 patients who received VANFLYTA in the clinical trial, 2.3% had a QTcF >500 ms and 10% had an increase of >60 ms from baseline. The trial excluded patients with a QTcF ≥450 ms or other factors that increased the risk of QT prolongation or arrhythmic events (eg, NYHA Class III/IV congestive heart failure, hypokalemia, or a family history of long QT interval syndrome).
  • Avoid use in patients who are at significant risk of developing torsades de pointes, including uncontrolled or significant cardiac disease, recent myocardial infarction, heart failure, unstable angina, bradyarrhythmias, tachyarrhythmias, uncontrolled hypertension, high-degree atrioventricular block, severe aortic stenosis, or uncontrolled hypothyroidism.
  • During induction and consolidation, perform an ECG prior to initiation and then once weekly during VANFLYTA treatment or more frequently as clinically indicated. During maintenance, perform ECGs prior to initiation, once weekly for at least the first month following dose initiation and escalation, and as clinically indicated thereafter.
  • Perform ECG monitoring of the QT interval more frequently in patients who are at significant risk of developing QT interval prolongation and torsades de pointes, or following dose escalation.
  • Monitor and correct hypokalemia and hypomagnesemia prior to and during treatment. Maintain electrolytes in the normal range. Monitor electrolytes and ECGs more frequently in patients who experience diarrhea or vomiting.
  • Reduce the VANFLYTA dose if QTc increases to greater than 480 ms and less than 500 ms. Interrupt and reduce the VANFLYTA dose if QTc increases to greater than 500 ms. Permanently discontinue VANFLYTA in patients who develop recurrent QTc greater than 500 ms or QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.

VANFLYTA REMS

  • Requirements include:
    • Prescribers must be certified in the VANFLYTA REMS by enrolling and completing training.
    • Prescribers must counsel patients receiving VANFLYTA about the risk of QT prolongation, torsades de pointes, and cardiac arrest, and provide patients with a Patient Wallet Card.
    • Pharmacies that dispense VANFLYTA must be certified with the VANFLYTA REMS and must verify prescribers are certified through the VANFLYTA REMS.
  • Further information is available at www.VANFLYTAREMS.com or by telephone at 1-855-212-6670.

Embryo-Fetal Toxicity

  • Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with VANFLYTA and for 7 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with VANFLYTA and for 4 months after the last dose.

Adverse Reactions

  • The most common (>20%) adverse reactions, including laboratory abnormalities, were lymphocytes decreased (60%), potassium decreased (59%), albumin decreased (53%), phosphorus decreased (52%), alkaline phosphatase increased (51%), magnesium decreased (44%), febrile neutropenia (44%), diarrhea (42%), mucositis (38%), nausea (34%), calcium decreased (33%), abdominal pain (30%), sepsis (30%), neutropenia (29%), headache (28%), creatine phosphokinase increased (26%), vomiting (25%), and upper respiratory tract infection (21%).

Drug Interactions

  • Strong CYP3A Inhibitors: Reduce the VANFLYTA dose due to increased quizartinib concentrations.
  • Strong or Moderate CYP3A Inducers: Avoid concomitant use due to decreased quizartinib concentrations.

Use in Specific Populations

  • Advise women not to breastfeed during treatment with VANFLYTA and for one month after the last dose.

To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc., at 1-877-437-7763 or the FDA at 1-800-FDA-1088 or fda.gov/medwatch.


Please see Full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

VANFLYTA® (quizartinib) logo

This site is intended for US healthcare professionals.

To contact us with questions or concerns about a Daiichi Sankyo product, please call us: 1-877-4DS-PROD (1-877-437-7763).

  • Privacy Policy
  • Terms of Use
  • Contact Us
  • About Daiichi Sankyo
  • Site Map
Daiichi-Sankyo logo

VANFLYTA4U is a program of Daiichi Sankyo AccessCentral4U.
AccessCentral4U™ is a trademark of Daiichi Sankyo Company, Limited.
Trademarks are the property of their respective owners.
VANFLYTA® is a registered trademark of Daiichi Sankyo Company, Limited.
© 2025 Daiichi Sankyo, Inc. PP-US-VN-0884 10/25

You are leaving VANFLYTAHCP.com

The site you are linking to is not controlled or endorsed by Daiichi-Sankyo, and we are not responsible for the content.

Thank you for visiting.

CANCEL OK

Quizartinib (VANFLYTA) is a recommended treatment option across all 3 treatment phases specifically for FLT3-ITD+ AML15*

By the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®)

NCCN Category 1

NCCN Guidelines® recommend quizartinib (VANFLYTA) as an NCCN Category 1 treatment option for eligible patients specifically with FLT3-ITD+ AML for intensive induction in combination with standard 7+3 chemotherapy (daunorubicin or idarubicin)15

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.

†Reinduction after cytarabine-based induction: consider follow-up BM aspirate and biopsy 14-21 days after start of therapy and residual disease (if ambiguous, repeat BM biopsy within 7 days before proceeding with therapy).

‡Alternate dosing of cytarabine for postremission therapy has been reported. Doses of cytarabine ≥2 g/m2 should be used with caution in patients ≥60 years and patients with renal failure due to concern for neurotoxicity.

Quizartinib (VANFLYTA) in combination15:

  • Reinduction†
    • Standard 7+3 or 5+2 (daunorubicin or idarubicin) for the FLT3-ITD mutation only
  • Consolidation
    • Cytarabine‡: For intensive induction–eligible AML with the FLT3-ITD mutation only

Quizartinib (VANFLYTA) alone15:

  • Maintenance post-consolidation therapy* (Preferred for FLT3-ITD)
    • For patients with a history of a FLT3 mutation who previously received a FLT3 inhibitor and if no allogeneic HCT is planned

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.

†Reinduction after cytarabine-based induction: consider follow-up BM aspirate and biopsy 14-21 days after start of therapy and residual disease (if ambiguous, repeat BM biopsy within 7 days before proceeding with therapy).

‡Alternate dosing of cytarabine for postremission therapy has been reported. Doses of cytarabine ≥2 g/m2 should be used with caution in patients ≥60 years and patients with renal failure due to concern for neurotoxicity.

All recommendations are Category 2A unless otherwise noted.

*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.

Back to Top