Brand Name
Vanflyta
Generic Name
Quizartinib
View Brand Information FDA approval date: July 20, 2023
Classification: Kinase Inhibitor
Form: Tablet
What is Vanflyta (Quizartinib)?
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 that is FLT3 internal tandem duplication -positive as detected by an FDA-approved test [see Dosage and Administration.
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Brand Information
VANFLYTA (QUIZARTINIB)
WARNING: QT PROLONGATION, TORSADES DE POINTES, and CARDIAC ARREST
- VANFLYTA prolongs the QT interval in a dose- and concentration-related manner
- 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
1INDICATIONS AND USAGE
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
2DOSAGE FORMS AND STRENGTHS
Tablets:
- 17.7 mg quizartinib, white, round, film-coated, debossed with "DSC511"
- 26.5 mg quizartinib, yellow, round, film-coated, debossed with "DSC512"
3CONTRAINDICATIONS
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
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- QT Prolongation, Torsades de Pointes, and Cardiac Arrest
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
5DESCRIPTION
VANFLYTA (quizartinib) is a kinase inhibitor for oral use. The chemical name of quizartinib dihydrochloride is
VANFLYTA is supplied as film-coated tablets containing 20 mg and 30 mg quizartinib dihydrochloride equivalent to 17.7 mg or 26.5 mg of quizartinib, respectively. The inactive ingredients in the tablet core are hydroxypropyl betadex, magnesium stearate, and microcrystalline cellulose. The tablet coating consists of hypromellose, talc, titanium dioxide, and triacetin. The 26.5 mg tablet coating also contains ferric oxide.
6CLINICAL STUDIES
The efficacy of VANFLYTA in combination with chemotherapy was evaluated in QuANTUM-First (NCT02668653), a randomized, double-blind, placebo-controlled study of 539 patients with newly diagnosed FLT3-ITD positive AML. FLT3-ITD status was determined prospectively with a clinical trial assay and verified retrospectively using the companion diagnostic LeukoStrat
Patients were stratified by age (<60 versus ≥60 years), white blood cell count at diagnosis (<40×10
The two treatment groups were generally balanced with respect to baseline demographics and disease characteristics. Of the 539 randomized patients, the median age was 56 years (range 20-75 years); 46% were male; 60% were White, 29% were Asian, 1% were Black, and 10% were other races. Eighty-four percent had an Eastern Cooperative Oncology Group (ECOG) baseline performance status of 0 or 1. The majority of the patients (72%) had intermediate risk cytogenetics at baseline. FLT3-ITD variant allelic frequency (VAF) was 3-25% in 36% of patients, >25-50% in 52% of patients, and >50% in 12% of patients. NPM1 mutations were identified in 52% of patients.
A second course of induction was administered to 20% of the patients, 65% initiated at least one cycle of consolidation, and 39% initiated maintenance. Among the patients who entered maintenance, 64% completed at least 12 cycles, 36% completed at least 24 cycles, and 16% completed all 36 planned cycles of maintenance. Twenty-nine percent (157/539) of the patients underwent HSCT in first complete remission (CR). The overall rate of HSCT (including the following settings: first CR, induction failure, or salvage after relapse) was 54% (144/268) in the VANFLYTA plus standard chemotherapy arm versus 47% (128/271) in the placebo plus standard chemotherapy arm. All patients were followed for survival.
Efficacy was established on the basis of overall survival (OS), measured from the date of randomization until death by any cause. The primary analysis was conducted after a minimum follow-up of 24 months after the randomization of the last patient. The study demonstrated a statistically significant improvement in OS for the VANFLYTA arm [hazard ratio (HR) 0.78; 95% CI: 0.62, 0.98; 2-sided p=0.0324] (see
In an exploratory subgroup analysis of the 89/208 (43%) of patients who received maintenance therapy with VANFLYTA or placebo following consolidation chemotherapy, the OS HR was 0.40 (95% CI: 0.19, 0.84). Of 119/208 (57%) of patients who received maintenance therapy with VANFLYTA or placebo following HSCT, the OS HR was 1.62 (95% CI: 0.62, 4.22).
The CR rate in the VANFLYTA arm was 55% (95% CI: 48.7, 60.9) with a median duration of CR of 38.6 months (95% CI: 21.9, NE), and the CR rate in the placebo arm was 55% (95% CI: 49.2, 61.4) with a median duration of CR of 12.4 months (95% CI: 8.8, 22.7).
7HOW SUPPLIED/STORAGE AND HANDLING
VANFLYTA (quizartinib) is supplied as round, film-coated tablets, packaged in bottles with a child-resistant closure.
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
9PRINCIPAL DISPLAY PANEL - 17.7 mg Tablet Bottle Carton
NDC 65597-504-04
VANFLYTA
17.7 mg
Rx only
Swallow tablets whole. Do not cut,
Dispense accompanying
Daiichi-Sankyo
10PRINCIPAL DISPLAY PANEL - 26.5 mg Tablet Bottle Carton
NDC 65597-511-04
VANFLYTA
26.5 mg
Rx only
Swallow tablets whole. Do not cut,
Dispense accompanying
Daiichi-Sankyo
