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
Bevacizumab	US FDA	—	Efficacy supplement 2020-05-29 (see label)	approved	May 29, 2020	openfda
Bevacizumab	US FDA	—	Efficacy supplement 2018-06-13 (see label)	approved	Jun 13, 2018	openfda
Bevacizumab	US FDA	—	Efficacy supplement 2018-04-30 (see label)	approved	Apr 30, 2018	openfda
Bevacizumab	US FDA	—	Efficacy supplement 2017-12-05 (see label)	approved	Dec 5, 2017	openfda
Bevacizumab	US FDA	—	Efficacy supplement 2016-12-06 (see label)	approved	Dec 6, 2016	openfda
Bevacizumab	US FDA	—	Efficacy supplement 2014-11-14 (see label)	approved	Nov 14, 2014	openfda
Bevacizumab	US FDA	—	Efficacy supplement 2014-08-14 (see label)	approved	Aug 14, 2014	openfda
Bevacizumab	US FDA	—	Efficacy supplement 2013-01-23 (see label)	approved	Jan 23, 2013	openfda
Bevacizumab	US FDA	—	Efficacy supplement 2012-10-26 (see label)	approved	Oct 26, 2012	openfda
Bevacizumab	US FDA	—	Efficacy supplement 2009-07-31 (see label)	approved	Jul 31, 2009	openfda
Bevacizumab	US FDA	—	Efficacy supplement 2009-05-05 (see label)	approved	May 5, 2009	openfda
Bevacizumab	US FDA	—	Efficacy supplement 2008-02-22 (see label)	approved	Feb 22, 2008	openfda
Bevacizumab	US FDA	—	Efficacy supplement 2006-10-11 (see label)	approved	Oct 11, 2006	openfda
Bevacizumab	US FDA	—	Efficacy supplement 2006-06-20 (see label)	approved	Jun 20, 2006	openfda
Bevacizumab	US FDA	—	Efficacy supplement 2005-09-29 (see label)	approved	Sep 29, 2005	openfda
Bevacizumab	US FDA	Malignant Colorectal Neoplasm	Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment.	approved	Feb 26, 2004	openfda
Bevacizumab	US FDA	Lung Non-Squamous Non-Small Cell Carcinoma	Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.	approved	Feb 26, 2004	openfda
Bevacizumab	US FDA	Glioblastoma	Recurrent glioblastoma in adults.	approved	Feb 26, 2004	openfda
Bevacizumab	US FDA	Renal Cell Carcinoma	Metastatic renal cell carcinoma in combination with interferon alfa.	approved	Feb 26, 2004	openfda
Bevacizumab	US FDA	Hepatocellular Carcinoma	Hepatocellular Carcinoma (HCC) in combination with atezolizumab for the treatment of patients with unresectable or metastatic HCC who have not received prior systemic therapy	approved	Feb 26, 2004	openfda
Bevacizumab	US FDA	Malignant Cervical Neoplasm	Persistent, recurrent, or metastatic cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.	approved	Feb 26, 2004	openfda
Bevacizumab	US FDA	Malignant Colon Neoplasm	Limitations of Use : Avastin is not indicated for adjuvant treatment of colon cancer.	approved	Feb 26, 2004	openfda
Bevacizumab	US FDA	—	in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens • in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by Avastin as a single agent, for platinum-sensitive recurrent disease	approved	Feb 26, 2004	openfda
Bevacizumab	US FDA	Malignant Peritoneal Neoplasm	Epithelial ovarian, fallopian tube, or primary peritoneal cancer: in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, for stage III or IV disease following initial surgical resection	approved	Feb 26, 2004	openfda
Bevacizumab	US FDA	Malignant Colorectal Neoplasm	Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.	approved	Feb 26, 2004	openfda
Dasatinib	US FDA	—	Efficacy supplement 2025-08-01 (see label)	approved	Aug 1, 2025	openfda
Dasatinib	US FDA	—	1. INDICATIONS AND USAGE PHYRAGO is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. PHYRAGO is indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. PHYRAGO TM is a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. ( 1 , 14 ) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. ( 1 , 14 ) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. ( 1 , 14 ) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. ( 1 , 14 ) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. ( 1 , 14 )	approved	Dec 5, 2023	openfda
Dasatinib	US FDA	—	Efficacy supplement 2018-12-21 (see label)	approved	Dec 21, 2018	openfda
Dasatinib	US FDA	—	Efficacy supplement 2017-11-09 (see label)	approved	Nov 9, 2017	openfda
Dasatinib	US FDA	—	Efficacy supplement 2015-08-12 (see label)	approved	Aug 12, 2015	openfda
Dasatinib	US FDA	—	Efficacy supplement 2013-06-17 (see label)	approved	Jun 17, 2013	openfda
Dasatinib	US FDA	—	Efficacy supplement 2010-10-28 (see label)	approved	Oct 28, 2010	openfda
Dasatinib	US FDA	—	Efficacy supplement 2010-10-28 (see label)	approved	Oct 28, 2010	openfda
Dasatinib	US FDA	—	Efficacy supplement 2009-05-21 (see label)	approved	May 21, 2009	openfda
Dasatinib	US FDA	—	Efficacy supplement 2007-11-08 (see label)	approved	Nov 8, 2007	openfda
Dasatinib	US FDA	—	Efficacy supplement 2007-11-08 (see label)	approved	Nov 8, 2007	openfda
Dasatinib	US FDA	—	Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy. Dasatinib tablets are a kinase inhibitor indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. (1 , 14) adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. (1 , 14) adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. (1 , 14) pediatric patients 1 year of age and older with Ph+ CML in chronic phase. (1 , 14) pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy. (1 , 14)	approved	Jun 28, 2006	openfda
Ivosidenib	US FDA	—	Efficacy supplement 2023-10-24 (see label)	approved	Oct 24, 2023	openfda
Ivosidenib	US FDA	—	Efficacy supplement 2022-05-25 (see label)	approved	May 25, 2022	openfda
Ivosidenib	US FDA	—	Efficacy supplement 2021-08-25 (see label)	approved	Aug 25, 2021	openfda
Ivosidenib	US FDA	—	Efficacy supplement 2019-05-02 (see label)	approved	May 2, 2019	openfda
Ivosidenib	US FDA	Acute Myeloid Leukemia	Newly Diagnosed Acute Myeloid Leukemia (AML) In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy	approved	Jul 20, 2018	openfda
Ivosidenib	US FDA	Cholangiocarcinoma	. Locally Advanced or Metastatic Cholangiocarcinoma For the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated	approved	Jul 20, 2018	openfda
Ivosidenib	US FDA	—	. Relapsed or refractory AML For the treatment of adult patients with relapsed or refractory AML	approved	Jul 20, 2018	openfda
Ivosidenib	US FDA	Myelodysplastic Syndrome	. Relapsed or refractory Myelodysplastic Syndromes (MDS) For the treatment of adult patients with relapsed or refractory myelodysplastic syndromes	approved	Jul 20, 2018	openfda
Olaparib	US FDA	—	Efficacy supplement 2023-11-06 (see label)	approved	Nov 6, 2023	openfda
Olaparib	US FDA	—	Efficacy supplement 2023-05-31 (see label)	approved	May 31, 2023	openfda
Olaparib	US FDA	—	Efficacy supplement 2022-08-26 (see label)	approved	Aug 26, 2022	openfda
Olaparib	US FDA	—	Efficacy supplement 2022-03-11 (see label)	approved	Mar 11, 2022	openfda
Olaparib	US FDA	—	Efficacy supplement 2022-01-31 (see label)	approved	Jan 31, 2022	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)