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

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

Ponatinib

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

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

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 EUGIA-SUNITINIB (DIN 02548054) 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 02548062) 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 02548038) 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 TARO-SUNITINIB (DIN 02524074) 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 AURO-SUNITINIB (DIN 02532212) 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 SUTENT (DIN 02328607) under ATC L01EX01 SUNITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

withdrawnsource: Cancelled Pre Marketsince Mar 31, 2025

—

EU EMA

—

Gastrointestinal stromal tumour (GIST) Sunitinib Accord is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) Sunitinib Accord is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sunitinib Accord is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.

approved

Feb 11, 2021

ema

EU EMA

—

Gastrointestinal stromal tumour (GIST) Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib mesilate treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours with disease progression in adults. Experience with Sutent as first-line treatment is limited (see section 5.1).

approved

Jul 19, 2006

ema

US FDA

—

Efficacy supplement 2021-08-30 (see label)

approved

Aug 30, 2021

US FDA

—

Efficacy supplement 2019-05-07 (see label)

approved

May 7, 2019

US FDA

—

Efficacy supplement 2017-11-16 (see label)

approved

Nov 16, 2017

US FDA

—

Efficacy supplement 2011-05-20 (see label)

approved

May 20, 2011

US FDA

—

Efficacy supplement 2010-07-01 (see label)

approved

Jul 1, 2010

US FDA

—

Efficacy supplement 2007-02-02 (see label)

approved

Feb 2, 2007

US FDA

—

Efficacy supplement 2007-02-02 (see label)

approved

Feb 2, 2007

US FDA

—

Efficacy supplement 2007-02-02 (see label)

approved

Feb 2, 2007

US FDA

—

treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. • adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.

approved

Jan 26, 2006

US FDA

Renal Cell Carcinoma

treatment of adult patients with advanced renal cell carcinoma (RCC).

approved

Jan 26, 2006

Primitive Neuroectodermal Tumor

US FDA

treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.

approved

Jan 26, 2006

CA Health Canada

—

Marketed in Canada as JAMP TRETINOIN (DIN 02520036) under ATC L01XF01 TRETINOIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Aug 29, 2022

CA Health Canada

—

Marketed in Canada as VESANOID (DIN 02145839) under ATC L01XF01 TRETINOIN. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.

approvedsource: Marketed

Dec 31, 1995

US FDA

—

ALTRENO ® (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. ALTRENO is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. (1)

approved

Aug 23, 2018

US FDA

—

Atralin Gel is indicated for topical treatment of acne vulgaris. Atralin Gel is a retinoid indicated for topical treatment of acne vulgaris. ( 1 )

approved

Jul 26, 2007

US FDA

—

Efficacy supplement 2002-05-10 (see label)

approved

May 10, 2002

US FDA

Malignant Skin Neoplasm

Patients with visible actinic keratosis and patients with a history of skin cancer were excluded from clinical trials of RENOVA (tretinoin cream) 0.02%. Thus the effectiveness and safety of RENOVA (tretinoin cream) 0.02% in these populations are not known at this time.

approved

Aug 31, 2000

US FDA

—

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) RENOVA (tretinoin cream) 0.02% is indicated as an adjunctive agent (see second bullet point below) for use in the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. RENOVA (tretinoin cream) 0.02% DOES NOT ELIMINATE WRINKLES, REPAIR SUN-DAMAGED SKIN, REVERSE PHOTOAGING, or RESTORE MORE YOUTHFUL or YOUNGER SKIN. In double-blind, vehicle-controlled clinical studies, many patients in the vehicle group achieved desired palliative effects on fine wrinkling of facial skin with the use of comprehensive skin care and sunlight avoidance programs including sunscreens, protective clothing, and non-prescription emollient creams. • RENOVA (tretinoin cream) 0.02% has NOT DEMONSTRATED A MITIGATING EFFECT on significant signs of chronic sunlight exposure such as coarse or deep wrinkling, tactile roughness, mottled hyperpigmentation, lentigines, telangiectasia, skin laxity, keratinocytic atypia, melanocytic atypia, or dermal elastosis. • RENOVA (tretinoin cream) 0.02% should be used under medical supervision as an adjunct to a comprehensive skin care and sunlight avoidance program that includes the use of effective sunscreens (minimum SPF of 15) and protective clothing. • Neither the safety nor the effectiveness of RENOVA (tretinoin cream) 0.02% for the prevention or treatment of actinic keratoses or skin neoplasms has been established. • Neither the safety nor the efficacy of using RENOVA (tretinoin cream) 0.02% daily for greater than 52 weeks has been established, and daily use beyond 52 weeks has not been systematically and histologically investigated in adequate and well-controlled trials (see WARNINGS ). Clinical Trials Four adequate and well-controlled multi-center trials and one single-center randomized, controlled trial were conducted involving a total of 324 evaluable patients treated with RENOVA (tretinoin cream) 0.02% and 332 evaluable patients treated with the vehicle cream on the face for 24 weeks with a comprehensive skin care and sun avoidance program, to assess the effects on fine and coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Patients were evaluated at baseline on a 10-unit scale and changes from that baseline rating were categorized as follows: Worsening: Increase of 1 unit or more. No improvement: No change. Minimal improvement: Reduction of 1 unit. Mild improvement: Reduction of 2 units. Moderate improvement: Reduction of 3 units or more. In these trials, the fine and coarse wrinkling, mottled hyperpigmentation, tactile roughness, and laxity of the facial skin were thought to be caused by multiple factors which included intrinsic aging or environmental factors, such as chronic sunlight exposure. Two of the five trials provided adequate demonstration of efficacy for mitigation of fine facial wrinkling. No two of the five trials adequately demonstrated efficacy for mitigation of coarse wrinkling, mottled hyperpigmentation, tactile skin roughness, and laxity. Data for fine wrinkling (the indication for which RENOVA (tretinoin cream) 0.02% demonstrated efficacy) from all five trials (four studies in lightly pigmented subjects with Fitzpatrick Skin Types I-III and one study in darkly pigmented subjects with Fitzpatrick Skin Types IV-VI) is provided below: FINE WRINKLING IN LIGHTLY PIGMENTED SUBJECTS Subjects Using RENOVA (tretinoin cream) 0.02% + CSP * (N=279) Vehicle + CSP * (N=280) A single-center study (N=107) in darkly pigmented, mostly African-American, subjects with Fitzpatrick Skin Types IV-VI demonstrated minimal or mild improvement in fine facial wrinkling in 43% of patients using Vehicle + CSP* compared to 29% of subjects using RENOVA (tretinoin cream) 0.02% + CSP*. Although fewer darkly pigmented subjects improved with RENOVA (tretinoin cream) 0.02% than with vehicle, these findings ma…

US FDA

—

RETIN-A MICRO ® is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. RETIN-A MICRO is a retinoid indicated for the topical treatment of acne vulgaris in adults and pediatric patients 12 years of age and older. ( 1)

approved

Feb 7, 1997

US FDA

—

Tretinoin Cream, USP is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of this product in the treatment of other disorders have not been established.

approved

Jan 14, 1997

US FDA

—

Tretinoin is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.

approved

Sep 16, 1988

US FDA

—

approved

Oct 17, 1978

US FDA

—

RETIN-A is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.

approved

Apr 18, 1975

US FDA

—

approved

Jul 19, 1974

US FDA

—

approved

Jan 26, 1973