Reference Detail

Contact

Missing content? – Request curation!

Request curation for specific Genes, Variants, or PubMed publications.

Have questions, comments, or suggestions? - Let us know!

Email us at : ckbsupport@jax.org

Ref Type
PMID
Authors
Title Vanflyta (quizartinib) FDA Drug Label
Journal Vol Issue Date Pages Journal Short Title
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216993
Abstract Text

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.

Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Quizartinib Quizartinib 101 4
Drug Name Trade Name Synonyms Drug Classes Drug Description
Quizartinib Vanflyta AC220 FLT3 Inhibitor 66 Vanflyta (quizartinib) is a small molecule that selectively inhibits FLT3, which may induce apoptosis and inhibit tumor growth (PMID: 19654408, PMID: 23497317). Vanflyta (quizartinib) is FDA-approved for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, in patients with newly diagnosed acute myeloid leukemia harboring FLT3 ITD mutations (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FLT3 exon 15 ins acute myeloid leukemia sensitive Quizartinib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (QuANTUM-First) that supported FDA approval, Vanflyta (quizartinib) in combination with induction and consolidation chemotherapy, followed by Vanflyta (quizartinib) maintenance improved median overall survival (31.9 vs 15.1 months, HR 0.78, p=0.032) compared to placebo in patients with newly-diagnosed acute myeloid leukemia harboring FLT3 internal tandem duplication (ITD; exon 14 insertion, exon 15 insertion) (PMID: 37116523; NCT02668653). detail... detail... 37116523
FLT3 exon 14 ins acute myeloid leukemia sensitive Quizartinib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (QuANTUM-First) that supported FDA approval, Vanflyta (quizartinib) in combination with induction and consolidation chemotherapy, followed by Vanflyta (quizartinib) maintenance improved median overall survival (31.9 vs 15.1 months, HR 0.78, p=0.032) compared to placebo in patients with newly-diagnosed acute myeloid leukemia harboring FLT3 internal tandem duplication (ITD; exon 14 insertion) (PMID: 37116523; NCT02668653). 37116523 detail...