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 51–100 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 V560_L576del1
Regorafenib Anhydrous

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

health-canada-dpd

Clinical trials

Active trials (63)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 35 recruiting · 11 active phase 3 · 501 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–50 of 63 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
NCT02465060	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)	active not recruiting	Phase 2

Literature

Linked publications (44)

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

pubmedPublishedShowing 26–44 of 44 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Thymic carcinoma with overexpression of mutated KIT and the response to imatinib.
· N Engl J Med · 2004 · PMID 15201427 · validated civic_curation pubmed
Major response to imatinib mesylate in KIT-mutated melanoma.
· J Clin Oncol · 2008 · PMID 18421059 · validated civic_curation pubmed
Sunitinib therapy for melanoma patients with KIT mutations.
· Clin Cancer Res · 2012 · PMID 22261812 · validated civic_curation pubmed
KIT as a therapeutic target in metastatic melanoma.
· JAMA · 2011 · PMID 21642685 · validated civic_curation pubmed

KIT N822K + KIT W557_K558del2
Regorafenib Anhydrous	Gastrointestinal Stromal Tumor	Predictive	D	Supports Resistance	3	accepted	EID4169 In a set of preclinical experiments associated with gastrointestinal stromal tumor, the effects of the tyrosine kinase inhibitor regorafenib on Ba/F3 cell lines harboring the primary regorafenib-sensi… (full text at CIViC) PMID 25239608 · Garner et al., 2014 · Open in CIViC	civic
Imatinib + SunitinibSubstitutes	Gastrointestinal Stromal Tumor	Predictive	D	Supports Resistance	4	accepted	EID7414 Several preclinical studies tested the effects of various tyrosine kinase inhibitors (TKIs) on Ba/F3 cell lines with primary TKI-sensitizing del 557-558 mutation, which induced IL-3 independent growth… (full text at CIViC) PMID 25239608 · Garner et al., 2014 · Open in CIViC	civic

KIT Exon 9 Mutation2
Sunitinib	Gastrointestinal Stromal Tumor	Predictive	B	Supports Sensitivity Response	3	accepted	EID1223 Primary tumor genotyping of 89 patients with metastatic GIST given 2nd-line sunitinib treatment after prior imatinib therapy failure, revealed an improved response to sunitinib in patients with KIT ex… (full text at CIViC) PMID 22439647 · Rutkowski et al., 2012 · Open in CIViC	civic
〃	Gastrointestinal Stromal Tumor	Predictive	B	Supports Sensitivity Response	3	accepted	EID1424 In a study of 78 patients with gastrointestinal stromal tumors treated with sunitinib, patients with Kit exon 9 mutations or wildtype (lacking KIT or PDGFRA mutations) showed increased progression fre… (full text at CIViC) PMID 18955458 · Heinrich et al., 2008 · Open in CIViC	civic

KIT W557_K558del3
Sunitinib	Gastrointestinal Stromal Tumor	Predictive	C	Supports Resistance	3	accepted	EID4082 Patients 11, 69, and 73 from a larger cohort of genotyped patients (n= 78) with imatinib resistant or intolerant gastrointestinal stromal tumors (GISTs) harbored a primary (pre-imatinib treatment) KIT… (full text at CIViC) PMID 18955458 · Heinrich et al., 2008 · Open in CIViC	civic
Regorafenib + SunitinibSubstitutes	Gastrointestinal Stromal Tumor	Predictive	D	Supports Sensitivity Response	2	accepted	EID4087 In an in vitro study, an IL3 independent Ba/F3 cell line expressing KIT W557_K558del primary activating mutation demonstrated sensitivity to sunitinib (IC50: 7 +/- 2nmol/L) and regorafenib (IC50: 30 … (full text at CIViC) PMID 25239608 · Garner et al., 2014 · Open in CIViC	civic
Imatinib	Malignant NeoplasmALIAS	Predictive	D	Does Not Support Resistance	2	accepted	EID2481 In an in vitro study of imatinib sensitivity, KIT W557_K558del was cloned into a plasmid by site-directed mutagenesis of KIT WT cDNA. Chinese hamster ovary cells were transiently transfected with the … (full text at CIViC) PMID 14645423 · Heinrich et al., 2003 · Open in CIViC	civic

KIT V560D3
Sunitinib	Gastrointestinal Stromal Tumor	Predictive	C	Supports Resistance	3	accepted	EID4122 Patient 72 from a larger cohort of genotyped patients (n= 78) with imatinib resistant or intolerant gastrointestinal stromal tumors (GISTs) harbored a primary (pre-imatinib treatment) KIT V560D mutati… (full text at CIViC) PMID 18955458 · Heinrich et al., 2008 · Open in CIViC	civic
Imatinib Mesylate	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	2	accepted	EID5348 In an in vitro study, Chinese hamster ovary cells expressing KIT V560D mutation demonstrated sensitivity to imatinib treatment (IC50 = 100 vs IC50 = 1000) when compared to Chinese hamster ovary cells … (full text at CIViC) PMID 18955458 · Heinrich et al., 2008 · Open in CIViC	civic
Sunitinib	Malignant NeoplasmALIAS	Predictive	D	Does Not Support Resistance	2	accepted	EID4077 In an in vitro study, Chinese hamster ovary cells expressing KIT V560D demonstrated comparable sensitivity to sunitinib treatment compared to cells expressing ligand activated wild-type KIT (IC50<100 … (full text at CIViC) PMID 18955458 · Heinrich et al., 2008 · Open in CIViC	civic

KIT L576P5
Sunitinib	Gastrointestinal Stromal Tumor	Predictive	C	Supports Resistance	2	accepted	EID4136 Patient 29 from a larger cohort of genotyped patients (n= 78) with imatinib resistant or intolerant gastrointestinal stromal tumors (GISTs) harbored a primary (pre-imatinib treatment) KIT L576P mutati… (full text at CIViC) PMID 18955458 · Heinrich et al., 2008 · Open in CIViC	civic
Dasatinib + Imatinib + NilotinibSubstitutes	Lung Non-Small Cell CarcinomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	accepted	EID303 Ba/F3 cells harboring the KIT L576P mutation are sensitive to nilotinib, imatinib and lower concentrations of dasatinib. PMID 17372901 · Antonescu et al., 2007 · Open in CIViC	civic
Dasatinib + ImatinibSubstitutes	Malignant NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	2	accepted	EID4141 In an in vitro study, COS-7 cells expressing KIT L576P activating mutation demonstrated sensitivity to imatinib and dasatinib treatments. Sensitivity was determined by assessing reduced mutant KIT aut… (full text at CIViC) PMID 25317746 · Vita et al., 2014 · Open in CIViC	civic
Dasatinib	Melanoma	Predictive	D	Supports Sensitivity Response	3	accepted	EID42 The melanoma cell line WM3211, which harbors the L576P mutation, is sensitive to dasatinib. Molecular modeling indicated the L576P mutation alters the conformation of KIT but did not alter the binding… (full text at CIViC) PMID 19671763 · Woodman et al., 2009 · Open in CIViC	civic
Imatinib + Nilotinib + SorafenibSubstitutes	Melanoma	Predictive	D	Supports Resistance	3	accepted	EID34 The melanoma cell line WM3211 (derived from an acral lentiginous melanoma), which harbors the L576P mutation, is not sensitive to imatinib, nilotinib, and sorafenib. Molecular modeling indicated the L… (full text at CIViC) PMID 19671763 · Woodman et al., 2009 · Open in CIViC	civic

KIT EXPRESSION3
Sunitinib	GlioblastomaCURATED_BROADER	Predictive	B	Supports Sensitivity Response	3	accepted	EID10180 Phase II trial of sunitinib in 40 patients with first recurrence of primary glioblastoma. Median PFS 2.2 mo, median OS 9.2 mo, 5 stable disease >=6 months, no objective responses, so primary study end… (full text at CIViC) PMID 24311637 · Hutterer et al., 2014 · Open in CIViC	civic
Imatinib	Malignant Endometrial NeoplasmCURATED_BROADER	Predictive	C	Supports Sensitivity Response	2	accepted	EID1024 Case Report of a 42-year old patient with low-grade endometrial stromal sarcoma. IHC was focally positive for CD117. Imatinib mesylate led to complete metabolic response (PET-CT). PMID 18607592 · Kalender et al., 2009 · Open in CIViC	civic
〃	Malignant Endometrial NeoplasmCURATED_BROADER	Predictive	C	Supports Sensitivity Response	2	accepted	EID1025 Case Report of a 41-year old patient with high-grade stromal endometrial sarcoma and a large abdominal and retroperitoneal mass progressing after chemotherapy. IHC for c-Kit was positive and treatment… (full text at CIViC) PMID 16487996 · Salvatierra et al., 2006 · Open in CIViC	civic

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Nilotinib	CA Health Canada	—	Marketed in Canada as PMS-NILOTINIB (DIN 02565005) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Nilotinib	CA Health Canada	—	Marketed in Canada as PMS-NILOTINIB (DIN 02564947) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Nilotinib	CA Health Canada	—	Marketed in Canada as REDDY-NILOTINIB (DIN 02556626) under ATC L01EA03 NILOTINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Nilotinib	EU EMA	Chronic Myeloid Leukemia, Philadelphia Chromosome Positive, BCR-ABL1 Positive	Nilotinib Accord is indicated for the treatment of: - adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, - adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, - paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.	approved	Aug 22, 2024	ema
Nilotinib	EU EMA	Chronic Myeloid Leukemia, Philadelphia Chromosome Positive, BCR-ABL1 Positive	Tasigna is indicated for the treatment of: adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, paediatric patients with Philadelphia chromosome positive CML in chronic phase with resistance or intolerance to prior therapy including imatinib. Tasigna is indicated for the treatment of: adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase, adult patients with chronic phase and accelerated phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib. Efficacy data in patients with CML in blast crisis are not available, paediatric patients with chronic phase Philadelphia chromosome positive CML with resistance or intolerance to prior therapy including imatinib.	approved	Nov 19, 2007	ema
Nilotinib	US FDA	—	Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.	approved	May 29, 2026	openfda
Nilotinib	US FDA	Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive	Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.	approved	May 29, 2026	openfda
Nilotinib	US FDA	Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive	Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.	approved	Feb 19, 2025	openfda
Nilotinib	US FDA	—	Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.	approved	Feb 19, 2025	openfda
Nilotinib	US FDA	Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive	Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.	approved	Nov 7, 2024	openfda
Nilotinib	US FDA	—	Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.	approved	Nov 7, 2024	openfda
Nilotinib	US FDA	—	Efficacy supplement 2021-09-23 (see label)	approved	Sep 23, 2021	openfda
Nilotinib	US FDA	—	Efficacy supplement 2021-09-23 (see label)	approved	Sep 23, 2021	openfda
Nilotinib	US FDA	—	Efficacy supplement 2018-03-22 (see label)	approved	Mar 22, 2018	openfda
Nilotinib	US FDA	—	Efficacy supplement 2017-12-22 (see label)	approved	Dec 22, 2017	openfda
Nilotinib	US FDA	—	Efficacy supplement 2015-01-27 (see label)	approved	Jan 27, 2015	openfda
Nilotinib	US FDA	—	Efficacy supplement 2014-01-22 (see label)	approved	Jan 22, 2014	openfda
Nilotinib	US FDA	—	Efficacy supplement 2012-12-20 (see label)	approved	Dec 20, 2012	openfda
Nilotinib	US FDA	—	Efficacy supplement 2011-11-18 (see label)	approved	Nov 18, 2011	openfda
Nilotinib	US FDA	—	Efficacy supplement 2011-01-14 (see label)	approved	Jan 14, 2011	openfda
Nilotinib	US FDA	—	Efficacy supplement 2010-06-17 (see label)	approved	Jun 17, 2010	openfda
Nilotinib	US FDA	Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive	Adult patients with chronic phase (CP) and accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy that included imatinib.	approved	Oct 29, 2007	openfda
Nilotinib	US FDA	Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positive	Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.	approved	Oct 29, 2007	openfda
Nilotinib	US FDA	—	Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.	approved	Oct 29, 2007	openfda
Ponatinib	CA Health Canada	—	Marketed in Canada as ICLUSIG (DIN 02437341) under ATC L01EA05 PONATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Dormantsince Aug 8, 2022	Jan 7, 2016	health-canada-dpd
Ponatinib	CA Health Canada	—	Marketed in Canada as ICLUSIG (DIN 02437333) under ATC L01EA05 PONATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 21, 2015	health-canada-dpd
Ponatinib	EU EMA	—	Iclusig is indicated as monotherapy in adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. Iclusig is indicated in combination with reduced-intensity chemotherapy in adult patients with newly diagnosed Ph+ ALL (see section 5.1).  Iclusig is indicated as monotherapy in paediatric patients 6 years of age or older with chronic phase chronic myeloid leukaemia (CP-CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. See sections 4.2 for the assessment of cardiovascular status prior to start of therapy and 4.4 for situations where an alternative treatment may be considered.accelerated	approved	Jul 1, 2013	ema
Ponatinib	US FDA	—	Efficacy supplement 2025-10-10 (see label)	approved	Oct 10, 2025	openfda
Ponatinib	US FDA	—	Efficacy supplement 2024-03-19 (see label)	approved	Mar 19, 2024	openfda
Ponatinib	US FDA	—	Efficacy supplement 2022-02-15 (see label)	approved	Feb 15, 2022	openfda
Ponatinib	US FDA	—	Efficacy supplement 2020-12-18 (see label)	approved	Dec 18, 2020	openfda
Ponatinib	US FDA	—	Efficacy supplement 2016-11-28 (see label)	approved	Nov 28, 2016	openfda
Ponatinib	US FDA	—	Efficacy supplement 2016-06-02 (see label)	approved	Jun 2, 2016	openfda
Ponatinib	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	openfda
Regorafenib	CA Health Canada	—	Marketed in Canada as STIVARGA (DIN 02403390) under ATC L01EX05 REGORAFENIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 2, 2013	health-canada-dpd
Regorafenib	EU EMA	—	Stivarga is indicated as monotherapy for the treatment of adult patients with: metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies - these include fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy; unresectable or metastatic gastrointestinal stromal tumors (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib; hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.	approved	Aug 26, 2013	ema
Regorafenib	US FDA	—	Efficacy supplement 2018-06-14 (see label)	approved	Jun 14, 2018	openfda
Regorafenib	US FDA	—	Efficacy supplement 2017-04-27 (see label)	approved	Apr 27, 2017	openfda
Regorafenib	US FDA	Hepatocellular Carcinoma	Hepatocellular carcinoma (HCC) who have been previously treated with sorafenib	approved	Sep 27, 2012	openfda
Regorafenib	US FDA	—	Locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.	approved	Sep 27, 2012	openfda
Regorafenib	US FDA	Malignant Colorectal Neoplasm	Metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy.	approved	Sep 27, 2012	openfda
Selumetinib	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	health-canada-dpd
Selumetinib	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	health-canada-dpd
Selumetinib	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	—	health-canada-dpd
Selumetinib	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	—	health-canada-dpd
Selumetinib	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	ema
Selumetinib	US FDA	—	Efficacy supplement 2025-11-19 (see label)	approved	Nov 19, 2025	openfda
Selumetinib	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	openfda
Selumetinib	US FDA	—	Efficacy supplement 2025-09-10 (see label)	approved	Sep 10, 2025	openfda
Selumetinib	US FDA	—	Efficacy supplement 2024-01-24 (see label)	approved	Jan 24, 2024	openfda