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

health-canada-dpd

Clinical trials

Active trials (332)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 184 recruiting · 50 active phase 3 · 857 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–50 of 332 active studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT02465060	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)	active not recruiting	Phase 2

Literature

Linked publications (25)

Publications linked to the scope gene(s) through PubMed entity edges; 25 per page, newest first.

pubmedPublishedShowing 1–25 of 25 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Ivosidenib in IDH1-mutant, chemotherapy-refractory cholangiocarcinoma (ClarIDHy): a multicentre, randomised, double-blind, placebo-controlled, phase 3 study.
· Lancet Oncol · 2020 · PMID 32416072 · validated civic_curation pubmed
Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma.
· N Engl J Med · 2023 · PMID 37272516 · validated civic_curation pubmed
Durable Remissions with Ivosidenib in IDH1-Mutated Relapsed or Refractory AML.
· N Engl J Med · 2018 · PMID 29860938 · validated civic_curation pubmed
IDH1 and IDH2 mutations in gliomas.
· N Engl J Med · 2009 · PMID 19228619 · validated civic_curation

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 Mutation4

Ivosidenib

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

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

Supports Sensitivity Response

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

Supports Sensitivity Response

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

Supports Sensitivity Response

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 R132C + IDH1 R132H1
Ivosidenib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	4	accepted	EID12903 Popovici-Muller et al. reported preliminary efficacy data from an ongoing phase 1 study of ivosidenib (AG-120) monotherapy in patients with IDH1-mutated malignancies. In patients with relapsed or refr… (full text at CIViC) PMID 29670690 · Popovici-Muller et al., 2018 · Open in CIViC	civic

IDH1 R132C + IDH1 R132H1

Ivosidenib

Acute Myeloid LeukemiaCURATED_BROADER

Predictive

Supports Sensitivity Response

accepted

EID12903

Popovici-Muller et al. reported preliminary efficacy data from an ongoing phase 1 study of ivosidenib (AG-120) monotherapy in patients with IDH1-mutated malignancies. In patients with relapsed or refr… (full text at CIViC)

PMID 29670690 · Popovici-Muller et al., 2018 · Open in CIViC

civic

IDH1 R1323
Ivosidenib	Cholangiocarcinoma	Predictive	A	Supports Sensitivity Response	5	accepted	EID10886 The multicenter randomized double-blind phase 3 study included patients with IDH1-mutant cholangiocarcinoma who had progressed on previous therapy. Patients were randomly assigned to Ivosidenib or pla… (full text at CIViC) PMID 32416072 · Abou-Alfa et al., 2020 · Open in CIViC	civic
Bevacizumab + SunitinibSubstitutes	High-Grade Glioma, NOS	Predictive	B	Supports Sensitivity Response	2	accepted	EID2020 In a clinical study of 63 recurrent glioma patients, the combined cohort of patients treated with either bevacizumab or sunitinib showed that those harboring IDH1 codon 132 mutation were associated wi… (full text at CIViC) PMID 22199315 · Lv et al., 2011 · Open in CIViC	civic
Dasatinib	Intrahepatic Cholangiocarcinoma	Predictive	D	Supports Sensitivity Response	4	accepted	EID6439 Through a high-throughput drug screen of a large panel of cancer cell lines, including 17 biliary tract cancers, this work found that IDH mutant (IDHm) ICC cells demonstrate a striking response to the… (full text at CIViC) PMID 27231123 · Saha et al., 2016 · Open in CIViC	civic

IDH1 R1323

Ivosidenib

Cholangiocarcinoma

Predictive

Supports Sensitivity Response

accepted

EID10886

The multicenter randomized double-blind phase 3 study included patients with IDH1-mutant cholangiocarcinoma who had progressed on previous therapy. Patients were randomly assigned to Ivosidenib or pla… (full text at CIViC)

PMID 32416072 · Abou-Alfa et al., 2020 · Open in CIViC

civic

Bevacizumab + SunitinibSubstitutes

High-Grade Glioma, NOS

Predictive

Supports Sensitivity Response

accepted

EID2020

In a clinical study of 63 recurrent glioma patients, the combined cohort of patients treated with either bevacizumab or sunitinib showed that those harboring IDH1 codon 132 mutation were associated wi… (full text at CIViC)

PMID 22199315 · Lv et al., 2011 · Open in CIViC

civic

Dasatinib

Intrahepatic Cholangiocarcinoma

Predictive

Supports Sensitivity Response

accepted

EID6439

Through a high-throughput drug screen of a large panel of cancer cell lines, including 17 biliary tract cancers, this work found that IDH mutant (IDHm) ICC cells demonstrate a striking response to the… (full text at CIViC)

PMID 27231123 · Saha et al., 2016 · Open in CIViC

civic

IDH1 Mutation + IDH2 MutationIDH1 IDH21
Vorasidenib	Glioma	Predictive	A	Supports Sensitivity Response	4	accepted	EID11708 In this study, 331 patients with IDH-mutant grade 2 gliomas were either given vorasidenib (n = 168) or a placebo (n = 163). A median PFS of 27.7 months was reported in the vorasidenib group, compared … (full text at CIViC) PMID 37272516 · Mellinghoff et al., 2023 · Open in CIViC	civic

IDH1 Mutation + IDH2 MutationIDH1 IDH21

Vorasidenib

Glioma

Predictive

Supports Sensitivity Response

accepted

EID11708

In this study, 331 patients with IDH-mutant grade 2 gliomas were either given vorasidenib (n = 168) or a placebo (n = 163). A median PFS of 27.7 months was reported in the vorasidenib group, compared … (full text at CIViC)

PMID 37272516 · Mellinghoff et al., 2023 · Open in CIViC

civic

IDH1 R132C + IDH1 R132G + IDH1 R132H + IDH1 R132L + IDH1 R132S1
Vorasidenib	Low Grade Glioma	Predictive	A	Supports Sensitivity Response	5	accepted	EID11508 This phase 3 clinical trial was conducted to assess the progression free survival in patients with IDH-mutant gliomas treated with Vorasidenib, an oral brain-penetrant inhibitor, which showed prelimin… (full text at CIViC) PMID 37272516 · Mellinghoff et al., 2023 · Open in CIViC	civic

IDH1 R132C + IDH1 R132G + IDH1 R132H + IDH1 R132L + IDH1 R132S1

Vorasidenib

Low Grade Glioma

Predictive

Supports Sensitivity Response

accepted

EID11508

This phase 3 clinical trial was conducted to assess the progression free survival in patients with IDH-mutant gliomas treated with Vorasidenib, an oral brain-penetrant inhibitor, which showed prelimin… (full text at CIViC)

PMID 37272516 · Mellinghoff et al., 2023 · 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

IDH1 R132H2

AGI-5198

OligodendrogliomaCURATED_BROADER

Predictive

Supports Sensitivity Response

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

Does Not Support Sensitivity Response

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 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
Temozolomide	EU EMA	Glioblastoma	Temozolomide Sun is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	approved	Jul 13, 2011	ema
Temozolomide	EU EMA	Glioblastoma	For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	withdrawn	Mar 15, 2010	ema
Temozolomide	EU EMA	Glioblastoma	For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	approved	Mar 15, 2010	ema
Temozolomide	EU EMA	Glioblastoma	For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	withdrawnsince Sep 15, 2022	Mar 15, 2010	ema
Temozolomide	EU EMA	Glioblastoma	For the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment. For the treatment of children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	approved	Jan 28, 2010	ema
Temozolomide	EU EMA	Glioblastoma	Temomedac hard capsules is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	approved	Jan 25, 2010	ema
Temozolomide	EU EMA	Glioblastoma	Temodal hard capsules is indicated for the treatment of: adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and subsequently as monotherapy treatment; children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.	approved	Jan 26, 1999	ema
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	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
Venetoclax	EU EMA	—	Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL): in combination with acalabrutinib with or without obinutuzumab  in combination with obinutuzumab in combination with ibrutinib   Venclyxto in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.   Venclyxto monotherapy is indicated for the treatment of CLL: in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor, or in the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B cell receptor pathway inhibitor.   Venclyxto in combination with a hypomethylating agent is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for intensive chemotherapy.	approved	Dec 4, 2016	ema
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
Venetoclax	US FDA	—	Efficacy supplement 2019-05-15 (see label)	approved	May 15, 2019	openfda
Venetoclax	US FDA	—	Efficacy supplement 2018-11-21 (see label)	approved	Nov 21, 2018	openfda

Drug

Jurisdiction · authority

Cancer

Indication

Status

Approval date

Source