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
NCT05482893	Spevatamig (PT886) as Monotherapy or in Combination With Chemo and/or Targeted Therapy and/or ICI, for the Treatment of Patients With Advanced Gastrointestinal Cancers, Including Gastric, Gastroesophageal Junction, Pancreatic Ductal or Biliary Tract Carcinomas (the TWINPEAK Study)

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
Bevacizumab	CA Health Canada	—	Marketed in Canada as VEGZELMA (DIN 02534177) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 14, 2023	health-canada-dpd
Bevacizumab	CA Health Canada	—	Marketed in Canada as VEGZELMA (DIN 02534185) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 1, 2023	health-canada-dpd
Bevacizumab	CA Health Canada	—	Marketed in Canada as AYBINTIO (DIN 02522837) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 27, 2022	health-canada-dpd
Bevacizumab	CA Health Canada	—	Marketed in Canada as AYBINTIO (DIN 02522829) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jun 27, 2022	health-canada-dpd
Bevacizumab	CA Health Canada	—	Marketed in Canada as ABEVMY (DIN 02522179) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 13, 2022	health-canada-dpd
Bevacizumab	CA Health Canada	—	Marketed in Canada as ABEVMY (DIN 02522160) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Apr 13, 2022	health-canada-dpd
Bevacizumab	CA Health Canada	—	Marketed in Canada as BAMBEVI (DIN 02520729) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 9, 2021	health-canada-dpd
Bevacizumab	CA Health Canada	—	Marketed in Canada as BAMBEVI (DIN 02520737) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 9, 2021	health-canada-dpd
Bevacizumab	CA Health Canada	—	Marketed in Canada as ZIRABEV (DIN 02489449) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 25, 2019	health-canada-dpd
Bevacizumab	CA Health Canada	—	Marketed in Canada as ZIRABEV (DIN 02489430) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Sep 25, 2019	health-canada-dpd
Bevacizumab	CA Health Canada	—	Marketed in Canada as MVASI (DIN 02470748) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 1, 2019	health-canada-dpd
Bevacizumab	CA Health Canada	—	Marketed in Canada as MVASI (DIN 02470756) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 1, 2019	health-canada-dpd
Bevacizumab	CA Health Canada	—	Marketed in Canada as AVASTIN (DIN 02270994) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Nov 2, 2005	health-canada-dpd
Bevacizumab	CA Health Canada	—	Marketed in Canada as BEVQOLVA (DIN 02567830) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Bevacizumab	CA Health Canada	—	Marketed in Canada as BEVQOLVA (DIN 02567865) under ATC L01FG01 BEVACIZUMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Bevacizumab	EU EMA	—	Treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer and recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer first-line treatment of patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer. first line treatment of patients with advanced and/or metastatic renal cell cancer.	approved	Jul 26, 2024	ema
Bevacizumab	EU EMA	—	VEGZELMA in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. VEGZELMA in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. VEGZELMA in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with VEGZELMA in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. VEGZELMA, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer (NSCLC) other than predominantly squamous cell histology. VEGZELMA, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent NSCLC with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1). VEGZELMA, in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. VEGZELMA, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1). VEGZELMA, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor–targeted agents. VEGZELMA in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents (see section 5.1). VEGZELMA, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).
Bevacizumab	EU EMA	—	Abevmy in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Abevmy in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Abevmy in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Abevmy in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Abevmy, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Abevmy, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1). Abevmy in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Abevmy, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics [FIGO] stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1). Abevmy, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Abevmy in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents (see section 5.1). Abevmy, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).
Bevacizumab	EU EMA	—	Alymsys in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Alymsys in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. Alymsys in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Alymsys in combination with capecitabine. Alymsys, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer other than predominantly squamous cell histology. Alymsys, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Alymsys in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Alymsys, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Alymsys, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Alymsys, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Alymsys, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.	approved	Mar 26, 2021
Bevacizumab	EU EMA	—	Oyavas in combination with fluoropyrimidine based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Oyavas in combination with paclitaxel is indicated for first line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Oyavas in combination with capecitabine is indicated for first line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Oyavas in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Oyavas, in addition to platinum based chemotherapy, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non small cell lung cancer other than predominantly squamous cell histology. Oyavas, in combination with erlotinib, is indicated for first line treatment of adult patients with unresectable advanced, metastatic or recurrent non squamous non small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1). Oyavas in combination with interferon alfa 2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Oyavas, in combination with carboplatin and paclitaxel is indicated for the front line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1). Oyavas, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Oyavas, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents (see Section 5.1). Oyavas, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1).
Bevacizumab	EU EMA	—	Onbevzi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Onbevzi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Onbevzi in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Onbevzi in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Onbevzi, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Onbevzi, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Onbevzi in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Onbevzi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Onbevzi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Onbevzi, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Onbevzi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.
Bevacizumab	EU EMA	—	Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline- containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Equidacent in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1. Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Bevacizumab in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1). Bevacizumab, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.	withdrawn	Sep 24, 2020	ema
Bevacizumab	EU EMA	—	Aybintio in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Aybintio in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1 of the SmPC. Aybintio in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Aybintio in combination with capecitabine. For further information as to HER2 status, please refer to section 5.1 of the SmPC. Aybintio, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Aybintio, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations (see section 5.1 of the SmPC). Aybintio in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Aybintio, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer (see section 5.1 of the SmPC). Aybintio, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents. Aybintio, in combination with topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor targeted agents (see section 5.1 of the SmPC). Aybintio, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix (see section 5.1 of the SmPC).
Bevacizumab	EU EMA	—	Zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Zirabev in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status. Zirabev, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Zirabev in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Zirabev, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.	approved	Feb 14, 2019	ema
Bevacizumab	EU EMA	—	Mvasi in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Mvasi in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1. Mvasi, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Mvasi in combination with interferon alfa-2a is indicated for first-line treatment of adult patients with advanced and/or metastatic renal cell cancer. Mvasi, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. Mvasi, in combination with carboplatin and gemcitabine or in combination with carboplatin and paclitaxel, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. Mvasi in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents. Mvasi, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.	approved	Jan 15, 2018	ema
Bevacizumab	EU EMA	—	Bevacizumab in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum. Bevacizumab in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. For further information as to human epidermal growth factor receptor 2 (HER2) status. Bevacizumab in combination with capecitabine is indicated for first-line treatment of adult patients with metastatic breast cancer in whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. Patients who have received taxane and anthracycline-containing regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine. For further information as to HER2 status. Bevacizumab, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology. Bevacizumab, in combination with erlotinib, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer with Epidermal Growth Factor Receptor (EGFR) activating mutations. Bevacizumab in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer. Bevacizumab, in combination with carboplatin and paclitaxel is indicated for the front-line treatment of adult patients with advanced (International Federation of Gynecology and Obstetrics (FIGO) stages III B, III C and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.Bevacizumab, in combination with carboplatin and gemcitabine, is indicated for treatment of adult patients with first recurrence of platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Bevacizumab in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin is indicated for the treatment of adult patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with bevacizumab or other VEGF inhibitors or VEGF receptor–targeted agents. Bevacizumab, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.
Bevacizumab	EU EMA	—	Treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.	withdrawnsince Jun 21, 2021	—	ema
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

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