Drug · Small Molecule

Sunitinib

CI-DRUG-00000564Explore in graph →NCIt C71622 CHEMBL535 CIViC Approved

Regulatory

Approvals (39)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory2 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
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

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 14 hours agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	33	14	43	361	39	CA, EU, US	Jan 26, 2006	2003-04
Malignant Kidney Neoplasm	Approved	Phase 4	10	1	18	116	1	US	Jan 26, 2006	2004-02
Malignant Lung Neoplasm	Phase4	Phase 4	2	1	2	24	0	—	—	2004-07
Malignant Breast Neoplasm	Phase4	Phase 4	1	0	0	15	0

Curated evidence

Clinical evidence (165)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 151–165 of 165 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
PDGFRA V561D1
Sunitinib	Malignant Neoplasm

Clinical trials

Trials with this intervention (387)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 51–100 of 387 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
NCT00720941	Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma(COMPARZ)	completed	Phase 3	1,110	Novartis PharmaceuticalsINDUSTRY	14	Mar 30, 2025	clinicaltrials
NCT00381641	Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery

Molecule

Record

Kind: Small Molecule
Mechanism: Macrophage colony stimulating factor receptor inhibitor; Stem cell growth factor receptor inhibitor; Tyrosine-protein kinase receptor FLT3 inhibitor; Platelet-derived growth factor receptor inhibitor; Vascular endothelial growth factor receptor inhibitor; Tyrosine-protein kinase receptor RET inhibitor; Vascular endothelial growth factor receptor 2 inhibitor; Platelet-derived growth factor receptor beta inhibitor; Platelet-derived growth factor receptor alpha inhibitor; Vascular endothelial growth factor receptor 1 inhibitor; Vascular endothelial growth factor receptor 3 inhibitor
Targets: 9 genes
UNII: LVX8N1UT73
Aliases: 1H-Pyrrole-3-carboxamide, N-(2-(diethylamino)ethyl)-5-((Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl)-2,4-dimethyl-, AURO-SUNITINIB, EUGIA-SUNITINIB, NAT-SUNITINIB, NSC-736511, NSC-750690, SANDOZ SUNITINIB, SU-011248, SU011248, SU-11248, Sunitinib, Sunitinib accord, Sunitinib Malate, SUNITINIB MALATE, SUTENT, TARO-SUNITINIB, TEVA-SUNITINIB

Data updated 17 hours agoSource updated unknown

Identifiers

Codes (55)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EX01

KIT D820Y1
Sunitinib	Melanoma	Predictive	D	Supports Sensitivity Response	2	accepted	EID2888 28 acral or mucosal melanomas were examined for KIT expression and mutations (exons 11, 13, 17, and 18). Two of 19 melanomas examined harbored KIT mutations, with one subject harboring a D820Y mutatio… (full text at CIViC) PMID 19035443 · Ashida et al., 2009 · Open in CIViC	civic

KIT D820Y1

Sunitinib

Melanoma

Predictive

Supports Sensitivity Response

accepted

EID2888

28 acral or mucosal melanomas were examined for KIT expression and mutations (exons 11, 13, 17, and 18). Two of 19 melanomas examined harbored KIT mutations, with one subject harboring a D820Y mutatio… (full text at CIViC)

PMID 19035443 · Ashida et al., 2009 · Open in CIViC

civic

KIT Exon 11 Mutation1
Sunitinib	Melanoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID1224 10 melanoma patients were evaluated after sunitinib treatment, among which 3 out of the 4 patients with KIT exon 11 mutations showed either complete or partial response. PMID 22261812 · Minor et al., 2012 · Open in CIViC	civic

KIT Exon 11 Mutation1

Sunitinib

Melanoma

Predictive

Supports Sensitivity Response

accepted

EID1224

10 melanoma patients were evaluated after sunitinib treatment, among which 3 out of the 4 patients with KIT exon 11 mutations showed either complete or partial response.

PMID 22261812 · Minor et al., 2012 · Open in CIViC

civic

PDGFRA Fusion1
Dasatinib + Masitinib + Midostaurin + Nilotinib + Ponatinib + Sorafenib + SunitinibSubstitutes	Myeloid/Lymphoid Neoplasms with Eosinophilia and Tyrosine Kinase Gene FusionsALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID1777 In a FIP1L1-PDGFRA positive eosinophil cell line growth-inhibitory effects were seen with all PDGFR-blocking agents, (ponatinib: 0.1-0.2nM, sorafenib: 0.1-0.2nM, masitinib: 0.2-0.5nM, nilotinib: 0.1-1… (full text at CIViC) PMID 24407160 · Sadovnik et al., 2014 · Open in CIViC	civic

PDGFRA Fusion1

Dasatinib + Masitinib + Midostaurin + Nilotinib + Ponatinib + Sorafenib + SunitinibSubstitutes

Myeloid/Lymphoid Neoplasms with Eosinophilia and Tyrosine Kinase Gene FusionsALIAS

Predictive

Supports Sensitivity Response

accepted

EID1777

In a FIP1L1-PDGFRA positive eosinophil cell line growth-inhibitory effects were seen with all PDGFR-blocking agents, (ponatinib: 0.1-0.2nM, sorafenib: 0.1-0.2nM, masitinib: 0.2-0.5nM, nilotinib: 0.1-1… (full text at CIViC)

PMID 24407160 · Sadovnik et al., 2014 · Open in CIViC

civic

PDGFRA Fusion + PDGFRA D842V1
Dasatinib + Imatinib + Masitinib + Nilotinib + Sorafenib + SunitinibSubstitutes	Myeloid/Lymphoid Neoplasms with Eosinophilia and Tyrosine Kinase Gene FusionsALIAS	Predictive	D	Supports Resistance	3	submitted	EID13087 Ba/F3 cells expressing two clinically relevant, imatinib-resistant, mutant forms of FIP1L1-PDGFRA, namely T674I and D842V were tested for growth inhibition by 8 PDGFR-blocking TKIs. Cells expressing D… (full text at CIViC) PMID 24407160 · Sadovnik et al., 2014 · Open in CIViC	civic

PDGFRA Fusion + PDGFRA D842V1

Dasatinib + Imatinib + Masitinib + Nilotinib + Sorafenib + SunitinibSubstitutes

Myeloid/Lymphoid Neoplasms with Eosinophilia and Tyrosine Kinase Gene FusionsALIAS

Predictive

Supports Resistance

submitted

EID13087

Ba/F3 cells expressing two clinically relevant, imatinib-resistant, mutant forms of FIP1L1-PDGFRA, namely T674I and D842V were tested for growth inhibition by 8 PDGFR-blocking TKIs. Cells expressing D… (full text at CIViC)

PMID 24407160 · Sadovnik et al., 2014 · Open in CIViC

civic

RET Overexpression1
Sunitinib	Papillary Adenocarcinoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID1518 A 78-year-old man presented with oral papillary adenocarcinoma and lung metastases that were refractory to standard treatment. Tumor sequencing showed increased MAPK activity due to RET over-expressi… (full text at CIViC) PMID 20696054 · Jones et al., 2010 · Open in CIViC	civic

RET Overexpression1

Sunitinib

Papillary Adenocarcinoma

Predictive

Supports Sensitivity Response

accepted

EID1518

A 78-year-old man presented with oral papillary adenocarcinoma and lung metastases that were refractory to standard treatment. Tumor sequencing showed increased MAPK activity due to RET over-expressi… (full text at CIViC)

PMID 20696054 · Jones et al., 2010 · Open in CIViC

civic

FLT3 T227M1

Sunitinib

Renal Cell CarcinomaCURATED_BROADER

Predictive

Supports Adverse Response

accepted

EID1317

In 219 patients with mostly Renal Cell Carcinoma and some Gastrointestinal Stromal tumors given sunitinib treatment, FLT3 T227M (rs1933437) was associated with the development of leukopenia. 95% confi… (full text at CIViC)

PMID 19667267 · van Erp et al., 2009 · Open in CIViC

civic

HMOX1 EXPRESSION1

Sorafenib + SunitinibSubstitutes

Renal Cell CarcinomaCURATED_BROADER

Predictive

Supports Resistance

accepted

EID829

In 66 patients with advanced renal cell carcinoma, high expression of heme oxygenase-1 (HO-1) was associated with poor overall response rate (2.6% versus 53.6%, P<0.01), clinical benefit rate (47.4% v… (full text at CIViC)

PMID 26309414 · Zheng et al., 2015 · Open in CIViC

civic

KDM5C Mutation1

Everolimus + SunitinibSequential

Renal Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID5997

This study evaluated the relationship between tumor mutations and treatment outcomes in the RECORD-3 clinical trial. With first-line everolimus, PBRM1 and BAP1 mutations were associated with longer (m… (full text at CIViC)

PMID 27751729 · Hsieh et al., 2017 · Open in CIViC

civic

PBRM1 Mutation1

Everolimus + SunitinibSequential

Renal Cell CarcinomaCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID5996

PMID 27751729 · Hsieh et al., 2017 · Open in CIViC

civic

PDGFRA Overexpression1

Sunitinib

Rhabdomyosarcoma

Predictive

Supports Sensitivity Response

accepted

EID7988

A high-throughput screen of 637 cancer cell lines revealed 2 to be sensitive to the multiple tyrosine kinase inhibitor, sunitinib. The most highly sensitive line was A-204, a rhabdomyosarcoma cell lin… (full text at CIViC)

PMID 19366796 · McDermott et al., 2009 · Open in CIViC

civic

PDGFRB Fusion1

Crenolanib + Dasatinib + Imatinib + Nilotinib + Ponatinib + Sorafenib + SunitinibSubstitutes

T Acute Lymphoblastic LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID13005

Primary mononuclear cells from a 4 year old patient with AGGF1:PDGFRb were treated with PDGFRb inhibitors, which resulted in cell death. IC50 for reduction in cell viability were approximately Ponatin… (full text at CIViC)

PMID 29284681 · Zabriskie et al., 2018 · Open in CIViC

civic

KIT V559G1

Sunitinib

Thymus Squamous Cell Carcinoma

Predictive

Supports Sensitivity Response

—

submitted

EID4116

An advanced thymic squamous cell carcinoma patient harboring a KIT V559G mutation was associated with partial response to sunitinib monotherapy. Upon identification of the KIT V559G mutation, the pat… (full text at CIViC)

PMID 27073655 · Hirai et al., 2016 · Open in CIViC

civic

PTPN12 Loss-of-function1

Crizotinib + SunitinibCombination

Triple-Negative Breast CarcinomaALIAS

Predictive

Supports Sensitivity Response

submitted

EID6931

Cancer-associated mutation of PTPN12 or reduced PTPN12 protein leads to aberrant activity of several tyrosine kinase receptors (MET, PDGFRβ, EGFR, and others). Restoring PTPN12 protein levels restrain… (full text at CIViC)

PMID 29578538 · Nair et al., 2018 · Open in CIViC

civic

VHL N78S (c.233A>G)1

Sunitinib

Von Hippel-Lindau DiseaseUNRESOLVED

Predictive

Supports Sensitivity Response

submitted

EID6429

A male patient with Type 1 VHL disease, clinical family history of VHL, and a history of retinal and CNS hemangioblastomas, presented with neuroendocrine tumor of the pancreas with metastases to the l… (full text at CIViC)

PMID 26984080 · Kobayashi et al., 2016 · Open in CIViC

civic