Biomarker · Gene alteration

IDH1 mutation

IDH1 codon 132 mutations detected by PCR or sequencing (or R132H-specific immunohistochemistry in glioma); used as a predictive marker for IDH1 inhibitors in acute myeloid leukemia and cholangiocarcinoma and as a diagnostic marker in glioma.

CI-BIO-00000047IDH1 graph →NCIt C118389

Also calledIDH1-mutated · IDH1 R132 · R132H · R132C

Derived

Associated cancers (13)

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
Acute Myeloid Leukemia	11	6	3	2	1 / 6 / 1 / 3 / 0
Anaplastic Astrocytoma	2	—	2	—	0 / 2 / 0 / 0 / 0
Cholangiocarcinoma	2	2	—	—	1 / 1 / 0 / 0 / 0
Glioblastoma	2	—	2	—	0 / 2 / 0 / 0 / 0
High-Grade Glioma, NOS

Derived

Drugs with predictive evidence (11)

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
IvosidenibSmall Molecule	6	6	—	A	6 / 0	Acute Myeloid Leukemia, Cholangiocarcinoma, Pancreatic Ductal Adenocarcinoma
VorasidenibSmall Molecule	2	2	—	A	6 / 0	Glioma

Curated evidence

Predictive evidence items (18)

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

civicCuratedShowing 1–18 of 18 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
IDH1 R132C6
BPTES	Acute Myeloid Leukemia

Regulatory

Approvals mentioning the linked drugs (260)

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

IDH1 Mutation4
Ivosidenib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	A	Supports Sensitivity Response	3	accepted	EID7278 I phase 1 trial for patients with IDH1-mutated AML, patients who received ivosidenib (AG-120). The rate of complete remission was 21.6%, the over all response rate was 30.4%. PMID 29860938 · DiNardo et al., 2018 · Open in CIViC	civic
Venetoclax	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	accepted	EID8856 In this case series, 7 elderly patients with secondary AML (sAML) not eligible for intensive chemotherapy and refractory to HMA (including 1 patient with antecedent myeloproliferative neoplasm) were t… (full text at CIViC) PMID 30725494 · Huemer et al., 2019 · Open in CIViC	civic
Ivosidenib	Cholangiocarcinoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID7447 In a phase1 trial, 73 patients with cholangiocarcinoma harboring IDH1 mutations were treated with mutant IDH1 inhibitor ivosidenib. The response rate was 5%, median progression free survival was 3.8 m… (full text at CIViC) PMID 31300360 · Lowery et al., 2019 · Open in CIViC	civic
Olaparib	Brain GliomaUNRESOLVED	Predictive	D	Supports Sensitivity Response	3	accepted	EID2933 Mutations in isocitrate dehydrogenase 1 and 2, which result in overproduction of 2-hydroxyglutarate (2HG). 2HG is considered to be an oncometabolite, or a metabolite that promotes carcinogenesis, and … (full text at CIViC) PMID 28148839 · Sulkowski et al., 2017 · Open in CIViC	civic

IDH1 R132H2
AGI-5198	OligodendrogliomaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	accepted	EID979 In pre-clinical studies, an IDH1 inhibitor (AG-5198) impaired growth of glioma / anaplastic oligodendroglioma cell lines with IDH1 R132H mutations. A phase I clinical trial of the AG-120 IDH1 inhibit… (full text at CIViC) PMID 23558169 · Rohle et al., 2013 · Open in CIViC	civic
Ivosidenib	Pancreatic Ductal Adenocarcinoma	Predictive	C	Does Not Support Sensitivity Response	2	accepted	EID5987 A 48-year-old female was diagnosed with metastatic pancreatic ductal adenocarcinoma and subsequently started on standard of care chemotherapy, during which her hepatic lesions progressed. Detailed mol… (full text at CIViC) PMID 27466707 · Brody et al., 2018 · Open in CIViC	civic

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
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 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	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 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 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	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	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
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
Temozolomide	CA Health Canada	—	Marketed in Canada as JAMP TEMOZOLOMIDE (DIN 02516802) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 5, 2022	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as JAMP TEMOZOLOMIDE (DIN 02516799) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 27, 2022	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as JAMP TEMOZOLOMIDE (DIN 02516829) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 26, 2022	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as JAMP TEMOZOLOMIDE (DIN 02516845) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 26, 2022	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as JAMP TEMOZOLOMIDE (DIN 02516810) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 25, 2022	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as ACH-TEMOZOLOMIDE (DIN 02438119) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jan 13, 2016	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TEVA-TEMOZOLOMIDE (DIN 02441160) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 8, 2015	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TARO-TEMOZOLOMIDE (DIN 02443511) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 23, 2015	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TARO-TEMOZOLOMIDE (DIN 02443554) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 23, 2015	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TARO-TEMOZOLOMIDE (DIN 02443538) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 23, 2015	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TARO-TEMOZOLOMIDE (DIN 02443481) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 23, 2015	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TARO-TEMOZOLOMIDE (DIN 02443473) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 23, 2015	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TEVA-TEMOZOLOMIDE (DIN 02395312) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 7, 2012	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TEVA-TEMOZOLOMIDE (DIN 02395274) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 7, 2012	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TEVA-TEMOZOLOMIDE (DIN 02395290) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 7, 2012	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TEVA-TEMOZOLOMIDE (DIN 02395282) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 7, 2012	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as ACH-TEMOZOLOMIDE (DIN 02389819) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 25, 2012	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as ACH-TEMOZOLOMIDE (DIN 02389835) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 25, 2012	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as ACH-TEMOZOLOMIDE (DIN 02389827) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 25, 2012	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as ACH-TEMOZOLOMIDE (DIN 02389843) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Feb 5, 2020	Jul 25, 2012	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as ACH-TEMOZOLOMIDE (DIN 02389851) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 25, 2012	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TEMODAL (DIN 02321262) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Feb 1, 2016	Dec 10, 2009	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TEMODAL (DIN 02312794) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Feb 21, 2009	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TEMODAL (DIN 02312816) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jul 22, 2011	Feb 21, 2009	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TEMODAL (DIN 02241094) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 12, 1999	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TEMODAL (DIN 02241093) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 12, 1999	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TEMODAL (DIN 02241095) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 12, 1999	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as TEMODAL (DIN 02241096) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 12, 1999	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as MAR-TEMOZOLOMIDE (DIN 02569337) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as MAR-TEMOZOLOMIDE (DIN 02569302) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd

Associated cancers (13)

Drugs with predictive evidence (11)

Predictive evidence items (18)

Approvals mentioning the linked drugs (260)

Active trials (332)

Linked publications (25)