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

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

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

Daunorubicin

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

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

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

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

US FDA

—

Efficacy supplement 2016-11-28 (see label)

approved

Nov 28, 2016

US FDA

—

Efficacy supplement 2016-06-02 (see label)

approved

Jun 2, 2016

US FDA

—

ICLUSIG ® is indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+ ALL in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. Chronic Myeloid Leukemia (CML) Chronic phase (CP) CML with resistance or intolerance to at least two prior kinase inhibitors. Accelerated phase (AP) or blast phase (BP) CML for whom no other kinase inhibitors are indicated. T315I-positive CML (chronic phase, accelerated phase, or blast phase). ICLUSIG is a kinase inhibitor indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+ ALL, in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). ( 1 ) As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. ( 1 ) Chronic Myeloid Leukemia (CML) Chronic phase (CP) CML with resistance or intolerance to at least two prior kinase inhibitors. ( 1 ) Accelerated phase (AP) or blast phase (BP) CML for whom no other kinase inhibitors are indicated. ( 1 ) T315I-positive CML (chronic phase, accelerated phase, or blast phase). ( 1 ) Limitations of Use : ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML. ( 5.7 ) Limitations of Use : ICLUSIG is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML [see Warnings and Precautions (5.7) ] .accelerated

approved

Dec 14, 2012

CA Health Canada

—

Marketed in Canada as VANFLYTA (DIN 02558378) under ATC L01EX11 QUIZARTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Mar 30, 2026

CA Health Canada

—

Marketed in Canada as VANFLYTA (DIN 02558351) under ATC L01EX11 QUIZARTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Oct 30, 2025

EU EMA

Acute Myeloid Leukemia

Vanflyta is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by Vanflyta single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukaemia (AML) that is FLT3-ITD positive.

approved

Nov 6, 2023

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) ] .

approved

Jul 20, 2023

CA Health Canada

—

Marketed in Canada as KOSELUGO (DIN 02530147) under ATC L01EE04 SELUMETINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 3, 2023

CA Health Canada

—

Marketed in Canada as KOSELUGO (DIN 02530139) under ATC L01EE04 SELUMETINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 3, 2023

CA Health Canada

—

Marketed in Canada as KOSELUGO GRANULES (DIN 02569736) under ATC L01EE04 SELUMETINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approved

—

CA Health Canada

—

Marketed in Canada as KOSELUGO GRANULES (DIN 02569744) under ATC L01EE04 SELUMETINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approved

—

EU EMA

—

Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in adult and paediatric patients with neurofibromatosis type 1 (NF1) aged 3 years and older. Koselugo as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in patients with neurofibromatosis type 1 (NF1) aged 1 year to less than 7 years and for older patients with swallowing difficulties.conditional

approved

Jun 17, 2021

US FDA

—

Efficacy supplement 2025-11-19 (see label)

approved

Nov 19, 2025

US FDA

—

Efficacy supplement 2025-09-10 (see label)

approved

Sep 10, 2025

US FDA

—

KOSELUGO is indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN) [see Dosage and Administration (2) ]. KOSELUGO is a kinase inhibitor indicated for the treatment of adult and pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). ( 1 )

approved

Sep 10, 2025

US FDA

—

Efficacy supplement 2024-01-24 (see label)

approved

Jan 24, 2024

US FDA

—

approved

Apr 10, 2020

CA Health Canada

—

Marketed in Canada as NEXAVAR (DIN 02284227) under ATC L01EX02 SORAFENIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jul 31, 2006

CA Health Canada

—

Marketed in Canada as APO-SORAFENIB (DIN 02490641) under ATC L01EX02 SORAFENIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approved

—

EU EMA

—

Hepatocellular carcinomaSorafenib Accord is indicated for the treatment of hepatocellular carcinoma (see section 5.1). Renal cell carcinomaSorafenib Accord is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.

approved

Nov 9, 2022

EU EMA

—

Hepatocellular carcinoma Nexavar is indicated for the treatment of hepatocellular carcinoma. Renal cell carcinoma Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy. Differentiated thyroid carcinoma Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.

approved

Jul 19, 2006

US FDA

—

Efficacy supplement 2017-12-22 (see label)

approved

Dec 22, 2017

US FDA

—

Efficacy supplement 2013-11-22 (see label)

approved

Nov 22, 2013

US FDA

—

Efficacy supplement 2007-11-16 (see label)

approved

Nov 16, 2007

US FDA

—

Efficacy supplement 2007-11-16 (see label)

approved

Nov 16, 2007

US FDA

—

Efficacy supplement 2007-11-16 (see label)

approved

Nov 16, 2007

US FDA

—

Efficacy supplement 2007-11-16 (see label)

approved

Nov 16, 2007

US FDA

Hepatocellular Carcinoma

NEXAVAR is a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma

approved

Dec 1, 2005

US FDA

Renal Cell Carcinoma

Advanced renal cell carcinoma

approved

Dec 1, 2005

Differentiated Thyroid Gland Carcinoma

US FDA

Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment

approved

Dec 1, 2005

CA Health Canada

—

Marketed in Canada as NAT-SUNITINIB (DIN 02539284) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Sep 30, 2025

CA Health Canada

—

Marketed in Canada as NAT-SUNITINIB (DIN 02552892) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Sep 30, 2025

CA Health Canada

—

Marketed in Canada as NAT-SUNITINIB (DIN 02552906) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Sep 30, 2025

CA Health Canada

—

Marketed in Canada as AURO-SUNITINIB (DIN 02532190) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Sep 18, 2023

CA Health Canada

—

Marketed in Canada as TEVA-SUNITINIB (DIN 02526220) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Sep 11, 2023

CA Health Canada

—

Marketed in Canada as TEVA-SUNITINIB (DIN 02526212) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Sep 11, 2023

CA Health Canada

—

Marketed in Canada as TEVA-SUNITINIB (DIN 02526204) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Sep 11, 2023

CA Health Canada

—

Marketed in Canada as AURO-SUNITINIB (DIN 02532204) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jul 21, 2023

CA Health Canada

—

Marketed in Canada as AURO-SUNITINIB (DIN 02532220) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jul 21, 2023

CA Health Canada

—

Marketed in Canada as SANDOZ SUNITINIB (DIN 02532867) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

May 24, 2023

CA Health Canada

—

Marketed in Canada as SANDOZ SUNITINIB (DIN 02532840) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

May 24, 2023

CA Health Canada

—

Marketed in Canada as SANDOZ SUNITINIB (DIN 02532883) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

May 24, 2023

CA Health Canada

—

Marketed in Canada as TARO-SUNITINIB (DIN 02524058) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jan 17, 2023

CA Health Canada

—

Marketed in Canada as TARO-SUNITINIB (DIN 02524066) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Sep 20, 2022

CA Health Canada

—

Marketed in Canada as TARO-SUNITINIB (DIN 02524082) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Sep 20, 2022

CA Health Canada

—

Marketed in Canada as SUTENT (DIN 02280795) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jun 22, 2006

CA Health Canada

—

Marketed in Canada as SUTENT (DIN 02280809) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jun 22, 2006

CA Health Canada

—

Marketed in Canada as SUTENT (DIN 02280817) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Jun 22, 2006

CA Health Canada

—

Marketed in Canada as SANDOZ SUNITINIB (DIN 02532875) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approved

—

CA Health Canada

—

Marketed in Canada as EUGIA-SUNITINIB (DIN 02548046) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approved

—