Biomarker · Gene alteration

KIT mutation

Activating KIT mutations (exon 9, 11, 13, 17 and others) detected by sequencing of tumor tissue or marrow; used as a predictive marker for KIT inhibitors in gastrointestinal stromal tumor and as a diagnostic marker in systemic mastocytosis.

CI-BIO-00000050KIT graph →NCIt C39712

Also calledc-KIT mutation · KIT exon 11 · KIT D816V · CD117

Derived

Associated cancers (15)

Cancers mapped in ACCEPTED CIViC predictive, prognostic or diagnostic items whose variant (molecular markers) or gene (gene-level markers) is in this biomarker's scope. Counts by type and native level; each row links to the cancer's evidence tab.

Computedrule biomarker-links-v1

Cancer	Items	Predictive	Prognostic	Diagnostic	Levels A / B / C / D / E
Gastrointestinal Stromal Tumor	69	64	4	1	2 / 19 / 23 / 25 / 0
Malignant Neoplasm	15	15	—	—	0 / 0 / 0 / 15 / 0
Melanoma	9	9	—	—	0 / 2 / 4 / 3 / 0
Acute Myeloid Leukemia	4	3	1	—	0 / 2 / 0 / 2 / 0
Systemic Mastocytosis

Derived

Drugs with predictive evidence (14)

Therapies named in in-scope PREDICTIVE CIViC items, plus targets of PREDICTS_RESPONSE_TO knowledge edges from in-scope variants. Sensitivity and resistance are counted separately and never merged into a verdict.

Computedrule biomarker-links-v1

Drug	CIViC items	Sensitivity	Resistance	Best level	Edges (S / R)	Cancer context
ImatinibSmall Molecule	61	37	24	A	31 / 21	Anal Melanoma, Chronic Leukemia, Chronic Myeloid Leukemia, BCR-ABL1 Positive, Gastrointestinal Stromal Tumor +7
SunitinibSmall Molecule	30	15

Curated evidence

Predictive evidence items (105)

ACCEPTED CIViC predictive items in scope, grouped by molecular profile and therapy with native level, direction and cancer context. 50 per page.

civicCuratedShowing 101–105 of 105 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
KIT D816V3
Imatinib

Regulatory

Approvals mentioning the linked drugs (253)

Approval records of the derived drug set, plus records whose indication text names this biomarker. Each record names its authority, jurisdiction, indication text and status — a drug approved in one jurisdiction for one indication is not 'approved' in general, and an approval listed here is not necessarily restricted to this biomarker.

Computedrule biomarker-links-v1

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Dasatinib	US FDA	—	Efficacy supplement 2025-08-01 (see label)	approved	Aug 1, 2025	openfda
Dasatinib	US FDA	—	1. INDICATIONS AND USAGE PHYRAGO is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. PHYRAGO is indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. PHYRAGO TM is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. ( 1 , 14 ) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. ( 1 , 14 ) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. ( 1 , 14 ) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. ( 1 , 14 ) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. ( 1 , 14 )	approved	Dec 5, 2023	openfda
Dasatinib	US FDA	—	Efficacy supplement 2018-12-21 (see label)	approved	Dec 21, 2018	openfda
Dasatinib	US FDA	—	Efficacy supplement 2017-11-09 (see label)	approved	Nov 9, 2017	openfda
Dasatinib	US FDA	—	Efficacy supplement 2015-08-12 (see label)	approved	Aug 12, 2015	openfda
Dasatinib	US FDA	—	Efficacy supplement 2013-06-17 (see label)	approved	Jun 17, 2013	openfda
Dasatinib	US FDA	—	Efficacy supplement 2010-10-28 (see label)	approved	Oct 28, 2010	openfda
Dasatinib	US FDA	—	Efficacy supplement 2010-10-28 (see label)	approved	Oct 28, 2010	openfda
Dasatinib	US FDA	—	Efficacy supplement 2009-05-21 (see label)	approved	May 21, 2009	openfda
Dasatinib	US FDA	—	Efficacy supplement 2007-11-08 (see label)	approved	Nov 8, 2007	openfda
Dasatinib	US FDA	—	Efficacy supplement 2007-11-08 (see label)	approved	Nov 8, 2007	openfda
Dasatinib	US FDA	—	Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. Dasatinib tablets are a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. (1 , 14) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. (1 , 14) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. (1 , 14) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. (1 , 14) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. (1 , 14)	approved	Jun 28, 2006	openfda
Imatinib	US FDA	—	Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. • Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. • Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). • Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST.	approved	Nov 22, 2024	openfda
Imatinib	US FDA	Malignant Gastrointestinal Stromal Tumor	Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).	approved	Nov 22, 2024	openfda
Imatinib	US FDA	Chronic Eosinophilic Leukemia, Not Otherwise Specified	Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown.	approved	Nov 22, 2024	openfda
Imatinib	US FDA	Acute Lymphoblastic Leukemia	Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.	approved	Nov 22, 2024	openfda
Imatinib	US FDA	Acute Lymphoblastic Leukemia	Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).	approved	Nov 22, 2024	openfda
Imatinib	US FDA	Myelodysplastic/Myeloproliferative Neoplasm	Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.	approved	Nov 22, 2024	openfda
Imatinib	US FDA	Aggressive Systemic Mastocytosis	Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown.	approved	Nov 22, 2024	openfda
Imatinib	US FDA	—	Efficacy supplement 2016-08-25 (see label)	approved	Aug 25, 2016	openfda
Imatinib	US FDA	—	Efficacy supplement 2015-01-30 (see label)	approved	Jan 30, 2015	openfda
Imatinib	US FDA	—	Efficacy supplement 2013-01-25 (see label)	approved	Jan 25, 2013	openfda
Imatinib	US FDA	—	Efficacy supplement 2012-01-31 (see label)	approved	Jan 31, 2012	openfda
Imatinib	US FDA	—	Efficacy supplement 2011-04-01 (see label)	approved	Apr 1, 2011	openfda
Imatinib	US FDA	—	Efficacy supplement 2009-05-27 (see label)	approved	May 27, 2009	openfda
Imatinib	US FDA	—	Efficacy supplement 2008-12-19 (see label)	approved	Dec 19, 2008	openfda
Imatinib	US FDA	—	Efficacy supplement 2008-09-26 (see label)	approved	Sep 26, 2008	openfda
Imatinib	US FDA	—	Efficacy supplement 2007-09-13 (see label)	approved	Sep 13, 2007	openfda
Imatinib	US FDA	—	Efficacy supplement 2006-10-19 (see label)	approved	Oct 19, 2006	openfda
Imatinib	US FDA	—	Efficacy supplement 2006-10-19 (see label)	approved	Oct 19, 2006	openfda
Imatinib	US FDA	—	Efficacy supplement 2006-10-19 (see label)	approved	Oct 19, 2006	openfda
Imatinib	US FDA	—	Efficacy supplement 2006-10-19 (see label)	approved	Oct 19, 2006	openfda
Imatinib	US FDA	—	Efficacy supplement 2006-10-19 (see label)	approved	Oct 19, 2006	openfda
Imatinib	US FDA	—	Efficacy supplement 2006-09-27 (see label)	approved	Sep 27, 2006	openfda
Imatinib	US FDA	—	Efficacy supplement 2005-10-20 (see label)	approved	Oct 20, 2005	openfda
Imatinib	US FDA	—	Efficacy supplement 2005-03-14 (see label)	approved	Mar 14, 2005	openfda
Imatinib	US FDA	—	Efficacy supplement 2003-12-08 (see label)	approved	Dec 8, 2003	openfda
Imatinib	US FDA	—	Efficacy supplement 2003-05-20 (see label)	approved	May 20, 2003	openfda
Imatinib	US FDA	Acute Lymphoblastic Leukemia	Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).	approved	Apr 18, 2003	openfda
Imatinib	US FDA	—	Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. • Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. • Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). • Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST.	approved	Apr 18, 2003	openfda
Imatinib	US FDA	Myelodysplastic/Myeloproliferative Neoplasm	Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.	approved	Apr 18, 2003	openfda
Imatinib	US FDA	Aggressive Systemic Mastocytosis	Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown.	approved	Apr 18, 2003	openfda
Imatinib	US FDA	Acute Lymphoblastic Leukemia	Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.	approved	Apr 18, 2003	openfda
Imatinib	US FDA	Malignant Gastrointestinal Stromal Tumor	Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).	approved	Apr 18, 2003	openfda
Imatinib	US FDA	Chronic Eosinophilic Leukemia, Not Otherwise Specified	Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown.	approved	Apr 18, 2003	openfda
Imatinib Mesylate	US FDA	—	Efficacy supplement 2016-08-25 (see label)	approved	Aug 25, 2016	openfda
Imatinib Mesylate	US FDA	—	Efficacy supplement 2015-01-30 (see label)	approved	Jan 30, 2015	openfda
Imatinib Mesylate	US FDA	—	Efficacy supplement 2013-01-25 (see label)	approved	Jan 25, 2013	openfda
Imatinib Mesylate	US FDA	—	Efficacy supplement 2012-01-31 (see label)	approved	Jan 31, 2012	openfda
Imatinib Mesylate	US FDA	—	Efficacy supplement 2011-04-01 (see label)	approved	Apr 1, 2011	openfda

Associated cancers (15)

Drugs with predictive evidence (14)

Predictive evidence items (105)

Approvals mentioning the linked drugs (253)

Active trials (63)

Linked publications (44)