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These highlights do not include all the information needed to use VANFLYTA safely and effectively. See full prescribing information for VANFLYTA. VANFLYTA® (quizartinib) tablets, for oral use Initial U.S. Approval: 2023
Medication labelWhy this: Advisory · dailymed-prescription
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 [see Dosage and Administration (2.1) and Clinical Studies (14)]. 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 [see Clinical Studies (14)].
- generic_name
- quizartinib
- product_names
- QUIZARTINIB
- ndc
- 65597-504, 65597-504-04, 65597-504-28, 65597-511, 65597-511-04, 65597-511-28
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en