Drug · Small Molecule

Quizartinib

CI-DRUG-00000495Explore in graph →NCIt C68936 CHEMBL576982 CIViC Approved

Regulatory

Approvals (4)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	Acute Myeloid Leukemia	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) ] . VANFLYTA is a kinase inhibitor 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. ( 1 ) 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. ( 1 ) 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) ] .

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 11 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	12	8	5	33	4	CA, EU, US	Jul 20, 2023	2007-01
Leukemia	Approved	Phase 3	11	7	5	32	2	EU, US	Jul 20, 2023	2007-01

Computedclinicaltrialsci-drug-pipeline-v1Stage rules

Curated evidence

Clinical evidence (22)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–22 of 22 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
FGF2 EXPRESSION1
Quizartinib	Acute Myeloid Leukemia

Clinical trials

Trials with this intervention (35)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–35 of 35 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT07478991	Azacytidine, Venetoclax Plus Minus Quizartinib for First Line Older/Unfit AML Patients (VENP-A-QUI)(VENP-A-QUI)	recruiting	Phase 3	376	PETHEMA FoundationOTHER	1	Sep 29, 2026	clinicaltrials
NCT03661307	Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

Molecule

Record

Kind: Small Molecule
Mechanism: Macrophage colony stimulating factor receptor inhibitor; Tyrosine-protein kinase receptor FLT3 inhibitor; Stem cell growth factor receptor inhibitor; Platelet-derived growth factor receptor inhibitor; Tyrosine-protein kinase receptor RET inhibitor
Targets: 6 genes
UNII: WK7Q6ZIZ10
Aliases: (2E)-N-(4-(3-Chloro-4-Fluoroanilino)-7-(((3S)-Oxolan-3-Yl)Oxy)Quinoxazolin-6-yl)-4-(Dimethylamino)but-2-Enamide, AC-010220, AC010220, AC010220.2HCL, AC 220, AC-220, AC220, AC220 (QUIZARTINIB), AC708, ASP 2689, ASP-2689, ASP2689, N-(5-tert-butyl-isoxazol-3-yl)-N'-{4-[7-(2-morpholin-4-yl-ethoxy)imidazo [2,1-b] [1,3] Benzothiazol 2-yl]phenyl}urea, Quizartinib, QUIZARTINIB (AC220), QUIZARTINIB DIHYDROCHLORIDE, Quizartinib Hydrochloride, Vanflyta, VANFLYTA

Data updated 14 hours agoSource updated unknown

Identifiers

Codes (6)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EX11	QUIZARTINIB
DIN (Health Canada)

FLT3 D593del1
Linifanib + Quizartinib + Sorafenib + SunitinibSubstitutes	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Does Not Support Sensitivity Response	3	submitted	EID11094 A panel of 13 FLT3 tyrosine kinase inhibitors was tested against Ba/F3 cells transfected with FLT3 D593del using MTT growth/survival assay, and results were compared to Ba/F3 cells transfected with FL… (full text at CIViC) PMID 28077790 · Nguyen et al., 2017 · Open in CIViC	civic

FLT3 D593del1

Linifanib + Quizartinib + Sorafenib + SunitinibSubstitutes

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Does Not Support Sensitivity Response

submitted

EID11094

A panel of 13 FLT3 tyrosine kinase inhibitors was tested against Ba/F3 cells transfected with FLT3 D593del using MTT growth/survival assay, and results were compared to Ba/F3 cells transfected with FL… (full text at CIViC)

PMID 28077790 · Nguyen et al., 2017 · Open in CIViC

FLT3 D8352
Ponatinib + QuizartinibSubstitutes	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Resistance	3	accepted	EID1036 An in-vitro saturation mutagenesis screen of 50 independently derived FLT3-ITD clones was performed to identify mutations that confer resistance to ponatinib. Mutations at 3 AL residues (D835 [n = 31]… (full text at CIViC) PMID 23430109 · Smith et al., 2013 · Open in CIViC	civic
Quizartinib + SorafenibSubstitutes	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Supports Resistance	4	accepted	EID1038 In an in-vitro study using an in vitro saturation mutagenesis assay, 4 residues with AC220 (quizartinib) resistance-conferring mutations in the kinase domain of FLT3-ITD were identified. Mutations at … (full text at CIViC) PMID 22504184 · Smith et al., 2012 · Open in CIViC	civic

FLT3 Y572del2
Crenolanib + Lestaurtinib + Midostaurin + Ponatinib + Quizartinib + SorafenibSubstitutes	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	5	submitted	EID9306 The construct supported IL-3 independent growth of Ba/F3 cells. It showed FLT-3 autophosphorylation and downstream signaling via STAT5, AKT, and ERK1/2 pathways. With IL-3 deprivation, the cells showe… (full text at CIViC) PMID 33914060 · Young et al., 2021 · Open in CIViC	civic
Quizartinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	submitted	EID12860 Ba/F3 cell lines expressing the variant FLT3 Y572del showed sensitivity to quizartinib comparable to the FLT3-ITD construct. PMID 33914060 · Young et al., 2021 · Open in CIViC	civic