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 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 TEVA-SUNITINIB (DIN 02526204) 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 APO-TEMOZOLOMIDE (DIN 02413035) 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)