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
Olaparib	US FDA	—	Efficacy supplement 2021-03-11 (see label)	approved	Mar 11, 2021	openfda
Olaparib	US FDA	—	Efficacy supplement 2020-12-07 (see label)	approved	Dec 7, 2020	openfda
Olaparib	US FDA	—	Efficacy supplement 2020-05-19 (see label)	approved	May 19, 2020	openfda
Olaparib	US FDA	—	Efficacy supplement 2020-05-08 (see label)	approved	May 8, 2020	openfda
Olaparib	US FDA	—	Efficacy supplement 2019-12-27 (see label)	approved	Dec 27, 2019	openfda
Olaparib	US FDA	—	Efficacy supplement 2019-07-01 (see label)	approved	Jul 1, 2019	openfda
Olaparib	US FDA	—	Efficacy supplement 2018-12-19 (see label)	approved	Dec 19, 2018	openfda
Olaparib	US FDA	—	Efficacy supplement 2018-09-26 (see label)	approved	Sep 26, 2018	openfda
Olaparib	US FDA	—	Efficacy supplement 2018-01-12 (see label)	approved	Jan 12, 2018	openfda
Olaparib	US FDA	Hormone Receptor-Positive Breast Carcinoma	for the treatment of adult patients with deleterious or suspected deleterious gBRCA m, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.	approved	Aug 17, 2017	openfda
Olaparib	US FDA	Malignant Peritoneal Neoplasm	in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: • a deleterious or suspected deleterious BRCA mutation, and/or • genomic instability. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.	approved	Aug 17, 2017	openfda
Olaparib	US FDA	Malignant Peritoneal Neoplasm	for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.	approved	Aug 17, 2017	openfda
Olaparib	US FDA	Castration-Resistant Prostate Carcinoma	Prostate cancer • for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.	approved	Aug 17, 2017	openfda
Olaparib	US FDA	Pancreatic Adenocarcinoma	Pancreatic cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCA m metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.	approved	Aug 17, 2017	openfda
Olaparib	US FDA	Malignant Breast Neoplasm	Breast cancer • for the adjuvant treatment of adult patients with deleterious or suspected deleterious g BRCA m human epidermal growth factor receptor 2 (HER2)-negative high risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.	approved	Aug 17, 2017	openfda
Olaparib	US FDA	Castration-Resistant Prostate Carcinoma	in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA -mutated ( BRCA m) metastatic castration-resistant prostate cancer (mCRPC). Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.	approved	Aug 17, 2017	openfda
Olaparib	US FDA	—	Ovarian cancer • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.	approved	Aug 17, 2017	openfda
Olutasidenib	US FDA	Acute Myeloid Leukemia	Relapsed or Refractory Acute Myeloid Leukemia REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14.1 )] . REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. ( 1 )	approved	Dec 1, 2022	openfda
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	US FDA	—	Efficacy supplement 2023-09-14 (see label)	approved	Sep 14, 2023	openfda
Temozolomide	US FDA	—	Efficacy supplement 2023-09-14 (see label)	approved	Sep 14, 2023	openfda
Temozolomide	US FDA	—	Efficacy supplement 2023-09-14 (see label)	approved	Sep 14, 2023	openfda
Temozolomide	US FDA	—	Efficacy supplement 2023-09-14 (see label)	approved	Sep 14, 2023	openfda
Temozolomide	US FDA	—	Efficacy supplement 2023-09-14 (see label)	approved	Sep 14, 2023	openfda
Temozolomide	US FDA	—	Efficacy supplement 2023-09-14 (see label)	approved	Sep 14, 2023	openfda
Temozolomide	US FDA	Anaplastic Astrocytoma	Anaplastic astrocytoma.	approved	Feb 27, 2009	openfda
Temozolomide	US FDA	Anaplastic Astrocytoma	Treatment of adults with refractory anaplastic astrocytoma.	approved	Feb 27, 2009	openfda
Temozolomide	US FDA	Anaplastic Astrocytoma	Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma.	approved	Feb 27, 2009	openfda
Temozolomide	US FDA	Glioblastoma	Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment.	approved	Feb 27, 2009	openfda
Temozolomide	US FDA	—	Efficacy supplement 2005-03-15 (see label)	approved	Mar 15, 2005	openfda
Temozolomide	US FDA	—	Efficacy supplement 2003-03-11 (see label)	approved	Mar 11, 2003	openfda
Temozolomide	US FDA	Anaplastic Astrocytoma	Treatment of adults with refractory anaplastic astrocytoma.	approved	Aug 11, 1999	openfda
Temozolomide	US FDA	Anaplastic Astrocytoma	Anaplastic astrocytoma.	approved	Aug 11, 1999	openfda
Temozolomide	US FDA	Anaplastic Astrocytoma	Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma.	approved	Aug 11, 1999	openfda
Temozolomide	US FDA	Glioblastoma	Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment.	approved	Aug 11, 1999	openfda
Venetoclax	US FDA	—	Efficacy supplement 2026-05-20 (see label)	approved	May 20, 2026	openfda
Venetoclax	US FDA	—	Efficacy supplement 2026-02-19 (see label)	approved	Feb 19, 2026	openfda
Venetoclax	US FDA	—	Efficacy supplement 2021-10-04 (see label)	approved	Oct 4, 2021	openfda
Venetoclax	US FDA	—	Efficacy supplement 2020-10-16 (see label)	approved	Oct 16, 2020	openfda
Venetoclax	US FDA	—	Efficacy supplement 2020-10-16 (see label)	approved	Oct 16, 2020	openfda

Associated cancers (13)

Drugs with predictive evidence (11)

Predictive evidence items (18)

Approvals mentioning the linked drugs (260)

Active trials (332)

Linked publications (25)