FLT3 mutation (ITD / TKD)

Clinical trials

Active trials (148)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 80 recruiting · 34 active phase 3 · 917 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–50 of 148 active 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
NCT05554393	Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)	recruiting

Literature

Linked publications (46)

Publications linked to the scope gene(s) through PubMed entity edges; 25 per page, newest first.

pubmedPublishedShowing 1–25 of 46 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated AML.
· N Engl J Med · 2019 · PMID 31665578 · validated civic_curation pubmed
Prognostic significance of FLT3 internal tandem duplication, nucleophosmin 1, and CEBPA gene mutations for acute myeloid leukemia patients with normal karyotype and younger than 60 years: a systematic review and meta-analysis.
· Ann Hematol · 2014 · PMID 24801015 · validated civic_curation pubmed
Midostaurin approved for FLT3-mutated AML.
· Blood · 2017 · PMID 28546144 · validated civic_curation pubmed
DNMT3A mutations in acute myeloid leukemia.
· N Engl J Med · 2010 · PMID 21067377 · validated

FLT3 D835V8
AS602868 + Tyrphostin AG 1296Substitutes	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID3034 Murine Ba/F3 cells with FLT3 D835V mutation were assessed as sensitive to both AS602868 and AG1296.(IC50 = 1.85uM and IC50 = 4.55uM, respectively) PMID 17330097 · Griessinger et al., 2007 · Open in CIViC	civic
Cytarabine + SunitinibCombination	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID3009 SU11248 + Cytarabin has a synergic effect on Murine Ba/F3 cells with FLT3 D835V mutation (Combination Index = 0.59 for ED50, Combination Index = 0.71 for ED75, Combination Index = 0.82 for ED90) PMID 15304385 · Yee et al., 2004 · Open in CIViC	civic
Daunorubicin + SunitinibCombination	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID3010 SU11248 + Daunorubicin has a synergic effect on Murine Ba/F3 cells with FLT3 D835V mutation. (Combination Index = 0.82 for ED50, Combination Index = 0.72 for ED75, Combination Index = 0.64 for ED90) PMID 15304385 · Yee et al., 2004 · Open in CIViC	civic
Gilteritinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	2	accepted	EID8518 Ba/F3 cells were transfected to express FLT3-ITD or FLT3 tyrosine kinase domain mutations. Immunoblots revealed gilteritinib IC50s of 0.7nM, 1.6nM, and 5nM for D835H, FLT3-ITD, and wildtype (cell line… (full text at CIViC) PMID 27908881 · Lee et al., 2017 · Open in CIViC	civic
Quizartinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Does Not Support Sensitivity Response	4	accepted	EID3012 Murine Ba/F3 cell line has a restrictive sensitivity to Quizartinib (AC220), a second generation class II tyrosine kinase inhibitor (IC50 for proliferation = 172nM, IC50 for induction of apoptosis = 8… (full text at CIViC) PMID 23497317 · Kampa-Schittenhelm et al., 2013 · Open in CIViC	civic
Sunitinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	—	accepted	EID4022 In a retrospective study of 15 acute myeloid leukemia patients, the patients with FLT3 D835 mutation (n=2) were associated with improved response to sunitinib treatment (2/2 vs. 2/7) compared to FLT3 … (full text at CIViC) PMID 15459012 · Fiedler et al., 2005 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Does Not Support Sensitivity Response	3	accepted	EID3008 Murine Ba/F3 cells with FLT3 D835V mutation were assessed as not sensitive to SU11248 (Sunitinib) with dose required to inhibit proliferation of cells to 50% of untreated controls ED50 = 110nM. PMID 15304385 · Yee et al., 2004 · Open in CIViC	civic
Tandutinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Resistance	3	accepted	EID3007 Murine Ba/F3 cells with FLT3-D835V mutations were evaluated as non-responsive to MLN518 (Tandutinib). Cells with single FLT3 (D835V) mutants were resistant to MLN518(IC50 > 10uM) whereas cells with FL… (full text at CIViC) PMID 15256420 · Clark et al., 2004 · Open in CIViC	civic

FLT3 D835V8

AS602868 + Tyrphostin AG 1296Substitutes

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID3034

Murine Ba/F3 cells with FLT3 D835V mutation were assessed as sensitive to both AS602868 and AG1296.(IC50 = 1.85uM and IC50 = 4.55uM, respectively)

PMID 17330097 · Griessinger et al., 2007 · Open in CIViC

Cytarabine + SunitinibCombination

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID3009

SU11248 + Cytarabin has a synergic effect on Murine Ba/F3 cells with FLT3 D835V mutation (Combination Index = 0.59 for ED50, Combination Index = 0.71 for ED75, Combination Index = 0.82 for ED90)

PMID 15304385 · Yee et al., 2004 · Open in CIViC

Daunorubicin + SunitinibCombination

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID3010

SU11248 + Daunorubicin has a synergic effect on Murine Ba/F3 cells with FLT3 D835V mutation. (Combination Index = 0.82 for ED50, Combination Index = 0.72 for ED75, Combination Index = 0.64 for ED90)

PMID 15304385 · Yee et al., 2004 · Open in CIViC

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID8518

Ba/F3 cells were transfected to express FLT3-ITD or FLT3 tyrosine kinase domain mutations. Immunoblots revealed gilteritinib IC50s of 0.7nM, 1.6nM, and 5nM for D835H, FLT3-ITD, and wildtype (cell line… (full text at CIViC)

PMID 27908881 · Lee et al., 2017 · Open in CIViC

Quizartinib

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Does Not Support Sensitivity Response

accepted

EID3012

Murine Ba/F3 cell line has a restrictive sensitivity to Quizartinib (AC220), a second generation class II tyrosine kinase inhibitor (IC50 for proliferation = 172nM, IC50 for induction of apoptosis = 8… (full text at CIViC)

PMID 23497317 · Kampa-Schittenhelm et al., 2013 · Open in CIViC

Sunitinib

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

—

accepted

EID4022

In a retrospective study of 15 acute myeloid leukemia patients, the patients with FLT3 D835 mutation (n=2) were associated with improved response to sunitinib treatment (2/2 vs. 2/7) compared to FLT3 … (full text at CIViC)

PMID 15459012 · Fiedler et al., 2005 · Open in CIViC

〃

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Does Not Support Sensitivity Response

accepted

EID3008

Murine Ba/F3 cells with FLT3 D835V mutation were assessed as not sensitive to SU11248 (Sunitinib) with dose required to inhibit proliferation of cells to 50% of untreated controls ED50 = 110nM.

PMID 15304385 · Yee et al., 2004 · Open in CIViC

Tandutinib

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID3007

Murine Ba/F3 cells with FLT3-D835V mutations were evaluated as non-responsive to MLN518 (Tandutinib). Cells with single FLT3 (D835V) mutants were resistant to MLN518(IC50 > 10uM) whereas cells with FL… (full text at CIViC)

PMID 15256420 · Clark et al., 2004 · Open in CIViC

FLT3LG Expression + FLT3 OverexpressionFLT3LG FLT31
AG1295 + Crenolanib + R406Substitutes	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Does Not Support Sensitivity Response	3	accepted	EID11089 In some cancers such as infant ALL, B-lineage ALL and AML samples with the highest levels of wild-type FLT3, constitutive FLT3 phosphorylation is seen from paracrine or autocrine activation from FLT3 … (full text at CIViC) PMID 28077790 · Nguyen et al., 2017 · Open in CIViC	civic

FLT3LG Expression + FLT3 OverexpressionFLT3LG FLT31

AG1295 + Crenolanib + R406Substitutes

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Does Not Support Sensitivity Response

accepted

EID11089

In some cancers such as infant ALL, B-lineage ALL and AML samples with the highest levels of wild-type FLT3, constitutive FLT3 phosphorylation is seen from paracrine or autocrine activation from FLT3 … (full text at CIViC)

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

FLT3 ITD13
Daunorubicin	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Resistance	3	accepted	EID130 Ba/F3 cells with both FLT3-ITD and TKD mutations on the same allele have more resistance to daunorubicin than cells with FLT3-ITD alone. PMID 15626738 · Bagrintseva et al., 2005 · Open in CIViC	civic
Gilteritinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID8923 This study was designed to test the efficacy of FLT3 inhibitors in vitro against FLT3-ITD and other TKD variants clinically observed. IC50s were determined from immunoblots quantifying FLT3 phosphoryl… (full text at CIViC) PMID 27908881 · Lee et al., 2017 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	accepted	EID8924 In vitro gilteritinib treatment of MV4-11 and MOLM-13 cells, which endogenously express FLT3-ITD, showed growth suppression based on CellTiter GLO cytotoxicity assays with IC50 values of 0.92 nM (95% … (full text at CIViC) PMID 28516360 · Mori et al., 2017 · Open in CIViC	civic
Lestaurtinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID297 CEP701 was effective in reducing blast counts of 5/14 heavily pre-treated AML patients with FLT3 mutations. PMID 14726387 · Smith et al., 2004 · Open in CIViC	civic
Ponatinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	5	accepted	EID7369 In a preclinical trial, multiple experiments testing the effectiveness of ponatinib on the mutation FLT3-ITD in acute myeloid leukemia (AML) were conducted. Ponatinib was very effective in targeting t… (full text at CIViC) PMID 21482694 · Gozgit et al., 2011 · Open in CIViC	civic
Selumetinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Supports Resistance	2	accepted	EID1137 Forty-seven patients with relapsed/refractory AML or 60+ years old with untreated AML were enrolled on a phase II study. In FLT3 wild-type patients, six out of 36 (17%) had a response (1 PR, 3 MR, 2 u… (full text at CIViC) PMID 24178622 · Jain et al., 2014 · Open in CIViC	civic
Sorafenib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	4	accepted	EID298 Sorafenib is effective in patients with FLT3 internal tandem repeats, but not in wild type or D835 mutation. PMID 18230792 · Zhang et al., 2008 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	2	accepted	EID1040 13 patients with relapsed or chemo-refractory FLT3-ITD+ AML were treated with sorafenib (200-400 mg twice daily). 12 patients showed clearance or near clearance of bone marrow myeloblasts after 27 (ra… (full text at CIViC) PMID 22368270 · Man et al., 2012 · Open in CIViC	civic
〃	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	1	accepted	EID1555 Six children with relapsed or refractory FLT3-ITD-positive AML received initial therapy with sorafenib (alone or in combination with clofarabine and cytarabine). Four of the patients initially achiev… (full text at CIViC) PMID 23969938 · Baker et al., 2013 · Open in CIViC	civic
SU5614	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Resistance	3	accepted	EID131 Ba/F3 cells with both FLT3-ITD and TKD mutations on the same allele have more resistance to the protein tyrosine kinase (PTK) inhibitor SU5614 than cells with FLT3-ITD alone or FLT3 ITD and TKD mutati… (full text at CIViC) PMID 15626738 · Bagrintseva et al., 2005 · Open in CIViC	civic
Tretinoin	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	B	Supports Resistance	3	accepted	EID127 ATRA treatment did not effect overall survival in patients <60 years old with FLT3-ITD mutation. PMID 19965647 · Burnett et al., 2010 · Open in CIViC	civic
Tyrphostin AG 1296	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	accepted	EID299 AG1296 is effective in triggering apoptosis in Ba/F3 and primary AML cells with FLT3 internal tandem repeat. PMID 12357354 · Tse et al., 2002 · Open in CIViC	civic
Anthracycline Antineoplastic Antibiotic + TretinoinCombination	Acute Promyelocytic Leukemia	Predictive	B	Supports Resistance	4	accepted	EID1112 In a study of 171 APL patients treated with combination ATRA/anthracycline chemotherapy, FLT3 ITD mutations (n=35) were associated with lower 3-year OS compared to the FLT3 ITD-negative group (62% vs.… (full text at CIViC) PMID 24981688 · Lucena-Araujo et al., 2014 · Open in CIViC	civic

FLT3 ITD13

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID130

Ba/F3 cells with both FLT3-ITD and TKD mutations on the same allele have more resistance to daunorubicin than cells with FLT3-ITD alone.

PMID 15626738 · Bagrintseva et al., 2005 · Open in CIViC

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID8923

This study was designed to test the efficacy of FLT3 inhibitors in vitro against FLT3-ITD and other TKD variants clinically observed. IC50s were determined from immunoblots quantifying FLT3 phosphoryl… (full text at CIViC)

PMID 27908881 · Lee et al., 2017 · Open in CIViC

〃

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID8924

In vitro gilteritinib treatment of MV4-11 and MOLM-13 cells, which endogenously express FLT3-ITD, showed growth suppression based on CellTiter GLO cytotoxicity assays with IC50 values of 0.92 nM (95% … (full text at CIViC)

PMID 28516360 · Mori et al., 2017 · Open in CIViC

Lestaurtinib

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID297

CEP701 was effective in reducing blast counts of 5/14 heavily pre-treated AML patients with FLT3 mutations.

PMID 14726387 · Smith et al., 2004 · Open in CIViC

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID7369

In a preclinical trial, multiple experiments testing the effectiveness of ponatinib on the mutation FLT3-ITD in acute myeloid leukemia (AML) were conducted. Ponatinib was very effective in targeting t… (full text at CIViC)

PMID 21482694 · Gozgit et al., 2011 · Open in CIViC

Selumetinib

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID1137

Forty-seven patients with relapsed/refractory AML or 60+ years old with untreated AML were enrolled on a phase II study. In FLT3 wild-type patients, six out of 36 (17%) had a response (1 PR, 3 MR, 2 u… (full text at CIViC)

PMID 24178622 · Jain et al., 2014 · Open in CIViC

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID298

Sorafenib is effective in patients with FLT3 internal tandem repeats, but not in wild type or D835 mutation.

PMID 18230792 · Zhang et al., 2008 · Open in CIViC

〃

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID1040

13 patients with relapsed or chemo-refractory FLT3-ITD+ AML were treated with sorafenib (200-400 mg twice daily). 12 patients showed clearance or near clearance of bone marrow myeloblasts after 27 (ra… (full text at CIViC)

PMID 22368270 · Man et al., 2012 · Open in CIViC

〃

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID1555

Six children with relapsed or refractory FLT3-ITD-positive AML received initial therapy with sorafenib (alone or in combination with clofarabine and cytarabine). Four of the patients initially achiev… (full text at CIViC)

PMID 23969938 · Baker et al., 2013 · Open in CIViC

SU5614

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID131

Ba/F3 cells with both FLT3-ITD and TKD mutations on the same allele have more resistance to the protein tyrosine kinase (PTK) inhibitor SU5614 than cells with FLT3-ITD alone or FLT3 ITD and TKD mutati… (full text at CIViC)

PMID 15626738 · Bagrintseva et al., 2005 · Open in CIViC

Tretinoin

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID127

ATRA treatment did not effect overall survival in patients <60 years old with FLT3-ITD mutation.

PMID 19965647 · Burnett et al., 2010 · Open in CIViC

Tyrphostin AG 1296

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID299

AG1296 is effective in triggering apoptosis in Ba/F3 and primary AML cells with FLT3 internal tandem repeat.

PMID 12357354 · Tse et al., 2002 · Open in CIViC

Acute Promyelocytic Leukemia

Anthracycline Antineoplastic Antibiotic + TretinoinCombination

Predictive

Supports Resistance

accepted

EID1112

In a study of 171 APL patients treated with combination ATRA/anthracycline chemotherapy, FLT3 ITD mutations (n=35) were associated with lower 3-year OS compared to the FLT3 ITD-negative group (62% vs.… (full text at CIViC)

PMID 24981688 · Lucena-Araujo et al., 2014 · Open in CIViC

FLT3/ABL/Aurora Kinase Inhibitor KW-2449

FLT3 Y842C6
FLT3/ABL/Aurora Kinase Inhibitor KW-2449	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Resistance	3	accepted	EID8336 The authors used saturation mutagenesis of FLT3/ITD followed by selection of transfected cells in FLT3 TKI. The FLT3/ITD Y842C mutation produced high-level resistance to KW2449, sorafenib, sunitinib a… (full text at CIViC) PMID 22858906 · Williams et al., 2013 · Open in CIViC	civic
Lestaurtinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	accepted	EID8339 A screen using saturation mutagenesis of FLT3/ITD followed by selection of transfected TF1 cells in FLT3 TKIs identified Y842C. Cytotoxicity assessed by MTT demonstrated Ba/F3 cells expressing FLT3/IT… (full text at CIViC) PMID 22858906 · Williams et al., 2013 · Open in CIViC	civic
Midostaurin	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID8340 A screen using saturation mutagenesis of FLT3/ITD followed by selection of transfected TF1 cells in FLT3 TKIs identified Y842C. Cytotoxicity assessed by MTT demonstrated Ba/F3 cells expressing FLT3/IT… (full text at CIViC) PMID 22858906 · Williams et al., 2013 · Open in CIViC	civic
Quizartinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Resistance	3	accepted	EID8654 A screen using saturation mutagenesis of FLT3/ITD followed by selection of transfected TF1 cells in FLT3 TKIs identified Y842C. Cytotoxicity assessed by MTT demonstrated Ba/F3 cells expressing FLT3/IT… (full text at CIViC) PMID 22858906 · Williams et al., 2013 · Open in CIViC	civic
Sorafenib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Resistance	4	accepted	EID8337 The authors used saturation mutagenesis of FLT3/ITD followed by selection of transfected cells in FLT3 TKI. The FLT3/ITD Y842C mutation produced high-level resistance to KW2449, sorafenib, sunitinib a… (full text at CIViC) PMID 22858906 · Williams et al., 2013 · Open in CIViC	civic
Sunitinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Resistance	3	accepted	EID8338 The authors used saturation mutagenesis of FLT3/ITD followed by selection of transfected cells in FLT3 TKI. The FLT3/ITD Y842C mutation produced high-level resistance to KW2449, sorafenib, sunitinib a… (full text at CIViC) PMID 22858906 · Williams et al., 2013 · Open in CIViC	civic

FLT3 Y842C6

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID8336

The authors used saturation mutagenesis of FLT3/ITD followed by selection of transfected cells in FLT3 TKI. The FLT3/ITD Y842C mutation produced high-level resistance to KW2449, sorafenib, sunitinib a… (full text at CIViC)

PMID 22858906 · Williams et al., 2013 · Open in CIViC

Lestaurtinib

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID8339

A screen using saturation mutagenesis of FLT3/ITD followed by selection of transfected TF1 cells in FLT3 TKIs identified Y842C. Cytotoxicity assessed by MTT demonstrated Ba/F3 cells expressing FLT3/IT… (full text at CIViC)

PMID 22858906 · Williams et al., 2013 · Open in CIViC

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID8340

PMID 22858906 · Williams et al., 2013 · Open in CIViC

Quizartinib

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID8654

PMID 22858906 · Williams et al., 2013 · Open in CIViC

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID8337

PMID 22858906 · Williams et al., 2013 · Open in CIViC

Sunitinib

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID8338

PMID 22858906 · Williams et al., 2013 · Open in CIViC

FLT3 D835 + FLT3 I836 + FLT3 ITD1
Gilteritinib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	5	accepted	EID7728 In this phase 3 trial (ADMIRAL), 371 patients with relapsed or refractory FLT3-mutated AML (required to have FLT3 ITD or TKD D835 or I836 mutations) were randomly assigned in a 2:1 ratio to receive ei… (full text at CIViC) PMID 31665578 · Perl et al., 2019 · Open in CIViC	civic

FLT3 D835 + FLT3 I836 + FLT3 ITD1

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID7728

In this phase 3 trial (ADMIRAL), 371 patients with relapsed or refractory FLT3-mutated AML (required to have FLT3 ITD or TKD D835 or I836 mutations) were randomly assigned in a 2:1 ratio to receive ei… (full text at CIViC)

PMID 31665578 · Perl et al., 2019 · Open in CIViC

FLT3 Mutation2

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID7283

In a phase 1/2 trial, patients with refractory or relapsed AML with FLT3 mutation (n=191; ITD n=162, D835 n=13, ITD-D835 n=16) received gilteritinib. 49% (93/191) of patients achieved an overall respo… (full text at CIViC)

PMID 28645776 · Perl et al., 2017 · Open in CIViC

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID5261

Midostaurin is FDA-approved for the treatment of newly-diagnosed acute myeloid leukemia patients harboring FLT3 mutations.

PMID 28546144 · Levis, 2017 · Open in CIViC

FLT3 D835I1

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID8351

A 62-year-old female patient (AML5) was refractory to conventional chemotherapy and developed disease progression to quizartinib due to a D835I mutation. Using MTT to measure cytotoxicity, gilteritini… (full text at CIViC)

PMID 27908881 · Lee et al., 2017 · Open in CIViC

FLT3 D835H2

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID8517

Ba/F3 cells were transfected to express FLT3-ITD or FLT3 tyrosine kinase domain mutations. Immunoblots revealed gilteritinib IC50s of 2nM, 1.6nM, and 5nM for D835H, FLT3-ITD, and wildtype (cell line: … (full text at CIViC)

PMID 27908881 · Lee et al., 2017 · Open in CIViC

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID1556

Three children with relapsed or refractory FLT3-ITD-positive AML were treated with sorafenib. FLT3 mutations were assessed before treatment and at the time of resistance. During the initiation of the … (full text at CIViC)

PMID 23969938 · Baker et al., 2013 · Open in CIViC

FLT3 F691L2

Lestaurtinib

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID8341

A screen using saturation mutagenesis of FLT3/ITD followed by selection of transfected TF1 cells in FLT3 TKIs identified F691L. Cytotoxicity assessed by MTT demonstrated Ba/F3 cells expressing FLT3/IT… (full text at CIViC)

PMID 22858906 · Williams et al., 2013 · Open in CIViC

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID8342

A screen using saturation mutagenesis of FLT3/ITD followed by selection of transfected TF1 cells in the FLT3 TKI midostaurin identified F691L in 1 of 400 clones. Cytotoxicity assessed by MTT demonstra… (full text at CIViC)

PMID 22858906 · Williams et al., 2013 · Open in CIViC

FLT3 TKD MUTATION2

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID1295

In a phase 2 clinical study of 95 AML/high-risk MDS patients treated with either 50 or 100 mg midostaurin, 35 harbored FLT3 mutations (26 had FLT3 ITD, 9 had FLT3 D835Y mutations). A higher percentage… (full text at CIViC)

PMID 20733134 · Fischer et al., 2010 · Open in CIViC

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID248

Sorafenib is effective in patients with FLT3 internal tandem repeat mutations, but not in patients with wild type or D835 mutation.

PMID 18230792 · Zhang et al., 2008 · Open in CIViC

FLT3 N841I1

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID8858

Expression of the N841I variant in murine BaF3 cell line resulted in constitutive autophosphorylation of FLT3 and the amount of autophosphorylated FLT3 was decreased with exposure to the FLT3 inhibito… (full text at CIViC)

PMID 15178581 · Jiang et al., 2004 · Open in CIViC

FLT3 D593del1

Crenolanib + FLT3 Tyrosine Kinase Inhibitor TTT-3002 + Lestaurtinib + MidostaurinSubstitutes

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID11093

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 D8354

Ponatinib + QuizartinibSubstitutes

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

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

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID1039

13 patients with relapsed or chemo-refractory FLT3-ITD+ AML were treated with sorafenib (200-400 mg twice daily). 12 patients responded, but sorafenib response was lost in most patients after 72 (rang… (full text at CIViC)

PMID 22368270 · Man et al., 2012 · Open in CIViC

Quizartinib + SorafenibSubstitutes

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

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

SU5614

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID1037

An in-vitro cell-based screening approach generated FLT3-ITD-expressing cell lines resistant to the FLT3 inhibitors SU5614, PKC412, and sorafenib. SU5614 resistance mutations were limited to exchanges… (full text at CIViC)

PMID 19318574 · von Bubnoff et al., 2009 · Open in CIViC

FLT3 D835Y + FLT3 ITD1

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID247

In a trial with 13 patients with relapsed or refractory FLT3-ITD AML, considered unfit for further induction chemotherapy, D835Y emerged during resistance in three cases with initial sorafenib respons… (full text at CIViC)

PMID 22368270 · Man et al., 2012 · Open in CIViC

FLT3 D835H/Y1

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID1557

Mouse Ba/F3 cells with FLT3 mutations were evaluated for sorafenib resistance. Cells with single FLT3 (D835H/Y) mutants were resistant to sorafenib (IC50 81 nm/210 nM) whereas cells with FLT3 (ITD) m… (full text at CIViC)

PMID 23969938 · Baker et al., 2013 · Open in CIViC

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source

CA Health Canada

—

Marketed in Canada as CYTARABINE INJECTION (DIN 02515296) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Apr 21, 2022

CA Health Canada

—

Marketed in Canada as VYXEOS (DIN 02515490) under ATC L01XY01 CYTARABINE AND DAUNORUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jul 6, 2021

CA Health Canada

—

Marketed in Canada as PMS-CYTARABINE (DIN 02406764) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Dormantsince Jul 31, 2024

Jan 16, 2014

CA Health Canada

—

Marketed in Canada as PMS-CYTARABINE (DIN 02406772) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 16, 2014

CA Health Canada

—

Marketed in Canada as DEPOCYT (DIN 02241150) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Jun 29, 2017

Dec 29, 2000

CA Health Canada

—

Marketed in Canada as CYTARABINE INJECTION (DIN 02126656) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Sep 23, 1996

CA Health Canada

—

Marketed in Canada as CYTARABINE - PWS 2GM/VIAL (DIN 02167891) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Oct 26, 2015

Dec 31, 1995

CA Health Canada

—

Marketed in Canada as CYTARABINE - PWS 1GN/VIAL (DIN 02167883) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Oct 26, 2015

Dec 31, 1995

CA Health Canada

—

Marketed in Canada as CYTARABINE - PWS 500MG/VIAL (DIN 02167875) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Oct 26, 2015

Dec 31, 1995

CA Health Canada

—

Marketed in Canada as CYTARABINE-PWS 100MG/VIAL (DIN 02167867) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince May 7, 2018

Dec 31, 1995

CA Health Canada

—

Marketed in Canada as CYTARABINE INJ 100MG/ML (DIN 00885797) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Aug 13, 1998

Dec 31, 1992

CA Health Canada

—

Marketed in Canada as CYTOSAR (DIN 00646318) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Jul 4, 2025

Dec 31, 1986

CA Health Canada

—

Marketed in Canada as CYTOSAR (DIN 00646296) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Jul 4, 2025

Dec 31, 1986

CA Health Canada

—

Marketed in Canada as CYTOSAR (DIN 00194727) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Jul 4, 2025

Dec 31, 1977

CA Health Canada

—

Marketed in Canada as CYTOSAR (DIN 00386715) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Jul 4, 2025

Dec 31, 1977

CA Health Canada

—

Marketed in Canada as CYTARABINE INJECTION BP (DIN 02394901) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Pre Marketsince Aug 1, 2019

—

CA Health Canada

—

Marketed in Canada as CYTARABINE INJECTION, MYLAN STD. (DIN 02402203) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Pre Marketsince Feb 24, 2022

—

CA Health Canada

—

Marketed in Canada as CYTOSAR (DIN 02403838) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approved

—

CA Health Canada

—

Marketed in Canada as AJ-CYTARABINE (DIN 02404397) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Pre Marketsince Nov 3, 2015

—

CA Health Canada

—

Marketed in Canada as CYTOSAR (DIN 02403811) under ATC L01BC01 CYTARABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approved

—

EU EMA

—

Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

approved

Aug 23, 2018

EU EMA

Meningeal Lymphoma

Intrathecal treatment of lymphomatous meningitis. In the majority of patients such treatment will be part of symptomatic palliation of the disease.

withdrawn

Jul 11, 2001

US FDA

—

Cytarabine Injection in combination with other approved anti-cancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and pediatric patients. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection (preservative free preparations only) is indicated in the prophylaxis and treatment of meningeal leukemia.

approved

Jun 4, 1990

CA Health Canada

—

Marketed in Canada as DAUNORUBICIN INJECTABLE SOLUTION (DIN 02501481) under ATC L01DB02 DAUNORUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jun 2, 2026

CA Health Canada

—

Marketed in Canada as DAUNORUBICIN HYDROCHLORIDE INJECTION (DIN 02539209) under ATC L01DB02 DAUNORUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 31, 2024

CA Health Canada

—

Marketed in Canada as VYXEOS (DIN 02515490) under ATC L01XY01 CYTARABINE AND DAUNORUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jul 6, 2021

CA Health Canada

—

Marketed in Canada as DAUNORUBICIN HYDROCHLORIDE FOR INJECTION (DIN 02231420) under ATC L01DB02 DAUNORUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Apr 30, 2018

Mar 4, 1998

CA Health Canada

—

Marketed in Canada as DAUNOXOME LIPOSOMAL - IV 2MG/ML, 50MG/VIAL (DIN 02218046) under ATC L01DB02 DAUNORUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Post Marketsince Sep 21, 2001

Sep 22, 1997

CA Health Canada

—

Marketed in Canada as CERUBIDINE (DIN 01926683) under ATC L01DB02 DAUNORUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Dec 31, 1971

CA Health Canada

—

Marketed in Canada as DAUNORUBICIN INJECTABLE SOLUTION (DIN 02501473) under ATC L01DB02 DAUNORUBICIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approved

—

EU EMA

—

Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

approved

Aug 23, 2018

US FDA

—

Daunorubicin hydrochloride in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.

approved

Jan 30, 1998

CA Health Canada

—

Marketed in Canada as XOSPATA (DIN 02495058) under ATC L01EX13 GILTERITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Feb 3, 2020

EU EMA

Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.

approved

Oct 24, 2019

US FDA

—

Efficacy supplement 2019-05-29 (see label)

approved

May 29, 2019

US FDA

XOSPATA is a kinase inhibitor indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.

approved

Nov 28, 2018

CA Health Canada

—

Marketed in Canada as RYDAPT (DIN 02466236) under ATC L01EX10 MIDOSTAURIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Sep 8, 2017

EU EMA

Rydapt is indicated: in combination with standard daunorubicin and cytarabine induction and high dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation positive (see section 4.2); as monotherapy for the treatment of adult patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated haematological neoplasm (SM AHN), or mast cell leukaemia (MCL).

approved

Sep 18, 2017

US FDA

—

Efficacy supplement 2020-11-24 (see label)

approved

Nov 24, 2020

US FDA

Newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive as detected by an FDA-approved test, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.

approved

Apr 28, 2017

US FDA

approved

Apr 28, 2017

US FDA

—

Limitations of Use: RYDAPT is not indicated as a single-agent induction therapy for the treatment of patients with AML. Aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).

approved

Apr 28, 2017

US FDA

—

approved

Apr 28, 2017

CA Health Canada

—

Marketed in Canada as ICLUSIG (DIN 02437341) under ATC L01EA05 PONATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Dormantsince Aug 8, 2022

Jan 7, 2016

CA Health Canada

—

Marketed in Canada as ICLUSIG (DIN 02437333) under ATC L01EA05 PONATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Aug 21, 2015

EU EMA

—

Iclusig is indicated as monotherapy in adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL (see section 5.1).  Iclusig is indicated as monotherapy in paediatric patients 6 years of age or older with chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. See sections 4.2 for the assessment of cardiovascular status prior to start of therapy and 4.4 for situations where an alternative treatment may be considered.accelerated

approved

Jul 1, 2013

US FDA

—

Efficacy supplement 2025-10-10 (see label)

approved

Oct 10, 2025