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.

VANFLYTA common adverse reactions in FLT3-ITD+ AML

Most Common (>20%) ARs, including laboratory abnormalities1

Chart outlining laboratory abnormalities in patients receiving VANFLYTA + standard chemotherapy versus patients who received Placebo + standard chemotherapy Swipe to the left
Chart outlining laboratory abnormalities in patients receiving VANFLYTA + standard chemotherapy versus patients who received Placebo + standard chemotherapy

†The denominator used to calculate the rate varied from 199 to 260 in VANFLYTA + chemotherapy and from 187 to 267 in placebo + chemotherapy based on the number of patients with a baseline value and at least one post-treatment value.1

  • Serious ARs in ≥5% of patients who received VANFLYTA plus chemotherapy were: febrile neutropenia (11%). Fatal ARs occurred in 10% of patients who received VANFLYTA plus chemotherapy, including sepsis (5%), fungal infections (0.8%), brain edema (0.8%), and one case each of febrile neutropenia, pneumonia, cerebral infarction, acute respiratory distress syndrome, pulmonary embolism, ventricular dysfunction, and cardiac arrest1
  • With VANFLYTA, 34% of patients experienced a dose interruption due to ARs, 19% had a dose reduction, and 20% discontinued1
    • ARs which required dosage interruption in ≥2% of patients in the VANFLYTA arm included neutropenia (11%), thrombocytopenia (5%), and myelosuppression (3%)
    • ARs which required dosage reductions in ≥2% of patients in the VANFLYTA arm were neutropenia (9%), thrombocytopenia (5%), and electrocardiogram QT prolonged (4%)
    • The most frequent (≥2%) AR which resulted in permanent discontinuation in the VANFLYTA arm was sepsis (5%)

The VANFLYTA REMS

VANFLYTA is available only through a restricted distribution program under a Risk Evaluation and Mitigation Strategy (REMS) called the VANFLYTA REMS because of the serious risk of QT prolongation, torsades de pointes, and cardiac arrest.1

The VANFLYTA REMS includes the following:

  • 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

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VANFLYTA dosing

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.

AML=acute myeloid leukemia; AR=adverse reaction; FLT3=FMS (feline McDonough sarcoma)–like tyrosine kinase 3; HSCT=hematopoietic stem cell transplantation; ITD=internal tandem duplication; 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.