NDAORALTABLETPriority Review
Approved
Jul 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
21
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VANFLYTA (quizartinib) is an oral small-molecule FLT3 inhibitor approved by the FDA in July 2023 for acute myeloid leukemia (AML). It targets FLT3-internal tandem duplication (FLT3-ITD) mutations, a driver of aggressive AML with poor prognosis. The drug represents a targeted precision oncology approach for a molecularly defined patient subset.
$0.001BPart D
Peak7.0 years to LOEEarly peak-stage commercial performance with modest Part D utilization; team opportunity in market build-out phase post-approval.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (21)
Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission
Started Jul 2025
130 enrolled
Acute Myeloid LeukemiaLeukemia
Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML
Started Nov 2024
700 enrolled
Leukemia
Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects
Started Oct 2024
32 enrolled
Healthy Subjects
A Study to Evaluate QTc Prolongation With Quizartinib in Healthy Subjects Under Rapid Acceleration of Heart Rate
Started Oct 2024
70 enrolled
Healthy Subjects
Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment
Started Sep 2024
12 enrolled
Hepatic Impairment
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.