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
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
Temozolomide	CA Health Canada	—	Marketed in Canada as MAR-TEMOZOLOMIDE (DIN 02569299) 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 ACT TEMOZOLOMIDE (DIN 02395304) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Mar 17, 2021	—	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as APO-TEMOZOLOMIDE (DIN 02413116) 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 TEMOZOLOMIDE CAPSULES (DIN 02455757) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Apr 23, 2021	—	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as JAMP TEMOZOLOMIDE (DIN 02516837) 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 TARO-TEMOZOLOMIDE (DIN 02443546) 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 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
Temozolomide	CA Health Canada	—	Marketed in Canada as APO-TEMOZOLOMIDE (DIN 02413043) 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 APO-TEMOZOLOMIDE (DIN 02413124) 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 APO-TEMOZOLOMIDE (DIN 02413094) 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 APO-TEMOZOLOMIDE (DIN 02413132) 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 TEMOZOLOMIDE CAPSULES (DIN 02455749) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Apr 23, 2021	—	health-canada-dpd
Temozolomide	CA Health Canada	—	Marketed in Canada as MAR-TEMOZOLOMIDE (DIN 02569310) 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 02569345) 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 02569329) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Venetoclax	CA Health Canada	—	Marketed in Canada as VENCLEXTA (DIN 02458063) under ATC L01XX52 VENETOCLAX. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 31, 2016	health-canada-dpd
Venetoclax	CA Health Canada	—	Marketed in Canada as VENCLEXTA (DIN 02458039) under ATC L01XX52 VENETOCLAX. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 31, 2016	health-canada-dpd
Venetoclax	CA Health Canada	—	Marketed in Canada as VENCLEXTA (DIN 02458047) under ATC L01XX52 VENETOCLAX. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 31, 2016	health-canada-dpd
Venetoclax	CA Health Canada	—	Marketed in Canada as VENCLEXTA (DIN 02458055) under ATC L01XX52 VENETOCLAX. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 31, 2016	health-canada-dpd
Vorasidenib	CA Health Canada	—	Marketed in Canada as VORANIGO (DIN 02551233) under ATC L01XM04 VORASIDENIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 21, 2024	health-canada-dpd
Vorasidenib	CA Health Canada	—	Marketed in Canada as VORANIGO (DIN 02551225) under ATC L01XM04 VORASIDENIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Oct 21, 2024	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)