Biomarker · Gene alteration

PDGFRA mutation

Activating PDGFRA mutations, notably exon 18 D842V, detected by sequencing of tumor tissue; used as a predictive marker for PDGFRA-selective inhibitors in gastrointestinal stromal tumor.

CI-BIO-00000051PDGFRA graph →NCIt C39718

Also calledPDGFRA D842V · PDGFRA exon 18 · PDGFRA-mutant

Derived

Associated cancers (2)

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	8	7	—	1	0 / 4 / 2 / 2 / 0
Malignant Neoplasm	3	3	—	—	0 / 0 / 0 / 3 / 0

Derived

Drugs with predictive evidence (4)

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	6	—	6	B	0 / 6	Gastrointestinal Stromal Tumor, Malignant Neoplasm
SunitinibSmall Molecule	2	—	2	C	0 / 2	Gastrointestinal Stromal Tumor,

Curated evidence

Predictive evidence items (10)

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

civicCuratedShowing 1–10 of 10 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 D842V10
Crenolanib

Regulatory

Approvals mentioning the linked drugs (133)

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 (18)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 13 recruiting · 5 active phase 3 · 96 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–18 of 18 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
NCT07585266	A Study to Investigate Velzatinib Compared With Imatinib in Adult Participants With Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (StrateGIST Frontline)	recruiting	Phase 3

Literature

Linked publications (8)

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

pubmedPublishedShowing 1–8 of 8 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor.
· J Clin Oncol · 2003 · PMID 14645423 · validated civic_curation pubmed
PDGFRA mutations in gastrointestinal stromal tumors: frequency, spectrum and in vitro sensitivity to imatinib.
· J Clin Oncol · 2005 · PMID 15928335 · validated civic_curation pubmed
Molecular correlates of imatinib resistance in gastrointestinal stromal tumors.
· J Clin Oncol · 2006 · PMID 16954519 · validated civic_curation pubmed
Efficacy of Imatinib in Patients with Platelet-Derived Growth Factor Receptor Alpha-Mutated Gastrointestinal Stromal Tumors.
· Cancer Res Treat · 2016 · PMID 26130666 · validated

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Sunitinib	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	health-canada-dpd
Sunitinib	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	health-canada-dpd
Sunitinib	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	health-canada-dpd
Sunitinib	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	health-canada-dpd
Sunitinib	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	health-canada-dpd
Sunitinib	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	health-canada-dpd
Sunitinib	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	health-canada-dpd
Sunitinib	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	health-canada-dpd
Sunitinib	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	health-canada-dpd
Sunitinib	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	health-canada-dpd
Sunitinib	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	health-canada-dpd
Sunitinib	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	health-canada-dpd
Sunitinib	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	—	health-canada-dpd
Sunitinib	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	—	health-canada-dpd
Sunitinib	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	—	health-canada-dpd
Sunitinib	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	—	health-canada-dpd
Sunitinib	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	—	health-canada-dpd
Sunitinib	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	—	health-canada-dpd
Sunitinib	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	—	health-canada-dpd
Sunitinib	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	—	health-canada-dpd
Sunitinib	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
Sunitinib	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
Sunitinib	US FDA	—	Efficacy supplement 2021-08-30 (see label)	approved	Aug 30, 2021	openfda
Sunitinib	US FDA	—	Efficacy supplement 2019-05-07 (see label)	approved	May 7, 2019	openfda
Sunitinib	US FDA	—	Efficacy supplement 2017-11-16 (see label)	approved	Nov 16, 2017	openfda
Sunitinib	US FDA	—	Efficacy supplement 2011-05-20 (see label)	approved	May 20, 2011	openfda
Sunitinib	US FDA	—	Efficacy supplement 2010-07-01 (see label)	approved	Jul 1, 2010	openfda
Sunitinib	US FDA	—	Efficacy supplement 2007-02-02 (see label)	approved	Feb 2, 2007	openfda
Sunitinib	US FDA	—	Efficacy supplement 2007-02-02 (see label)	approved	Feb 2, 2007	openfda
Sunitinib	US FDA	—	Efficacy supplement 2007-02-02 (see label)	approved	Feb 2, 2007	openfda
Sunitinib	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	openfda
Sunitinib	US FDA	Renal Cell Carcinoma	treatment of adult patients with advanced renal cell carcinoma (RCC).	approved	Jan 26, 2006	openfda
Sunitinib	US FDA	Primitive Neuroectodermal Tumor	treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in adult patients with unresectable locally advanced or metastatic disease.	approved	Jan 26, 2006	openfda