bevacizumab

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Ligands
bevacizumab

GtoPdb Ligand ID: 6771

Synonyms: Avastin® | rhuMAb-VEGF

bevacizumab is an approved drug (FDA (2004), EMA (2005))

Comment: Vascular endothelial growth factor A inhibitor.
Annotated peptide sequences for this antibody are available from its IMGT/mAb-DB record.

Biosimilars: Amgen's bevacizumab-awwb (Mvasi®) was the first bevacizumab biosimilar to be FDA approved. This and others are listed in the table below.

Name	Trade name	Company	Clinical Phase	Indications
bevacizumab-awwb	Mvasi	Amgen	Approved (FDA 2017)	Approved to treat a range of cancers, including certain colorectal, lung, brain, kidney and cervical cancers.
bevacizumab-bvzr; PF-06439535	Zirabev	Pfizer	Approved (EMA & FDA 2019)	Approved to treat a range of cancers, including certain colorectal, lung, brain, kidney, cervical and breast cancers, plus recurrent glioblastoma (FDA).
SB8	Aybintio	Samsung Bioepis	Approved (EMA 2020)	Approved to treat a range of advanced solid tumour types, in combination with a number of chemotherapeutic drugs.
FKB238	Equidacent	Centus Biotherapeutics	Approved (EMA 2020)	Approved to treat a range of advanced solid tumour types, in combination with a number of chemotherapeutic drugs.
bevacizumab; MYL-1402O	Abevmy	Mylan	Approved (EMA 2021)	As per originator reference product.
bevacizumab-maly; BEVZ92-MB02	Oyavas; Alymsys	STADA Arzneimittel/Amneal//mAbxience	Approved (EMA 2021; FDA 2022)	As per originator reference product: NOT adjuvant treatment of colon cancer
bevacizumab	Onbevzi	Samsung Bioepis/Biogen	Approved (EMA 2021)	As per originator reference product
bevacizumab-adcd; CT-P16	Vegzelma	Celltrion	Approved (EMA & FDA 2022)	Approved to treat a range of advanced solid tumours in combination with other cancer drugs: Colorectal, breast, ovarian, fallopian tube, peritoneal, and uterine neoplasms, non-small cell lung cancer, and renal cell carcinoma
bevacizumab-tnjn; BAT1706	Avzivi	Bio-Thera Solutions	Approved (FDA 2023)	Approved for use in the treatment of advanced lung and colorectal cancers

No information available.

No information available.

Summary of Clinical Use
Used as part of combination therapy for metastatic colorectal cancer and HER2-negative metastatic breast cancer. In August 2014 the US FDA granted additional approval for metastatic cervical cancer. In November 2014, FDA approval was extended to include a combination therapy of bevacizumab plus chemotherapy (paclitaxel, pegylated liposomal doxorubicin or topotecan) for platinum-resistant, recurrent ovarian cancer (based on findings from the Phase 3 AURELIA clinical trial NCT00976911). Additional Phase 2 clinical trial results are provided in [5]. In June 2018, FDA approval was further expanded to include the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, in patients with stage III or IV disease, and to be used after initial surgical resection [2] [4]. Clinical trials evaluating bevacizumab in combination with the immune checkpoint inhibitors ipilimumab (anti-CTLA4) or nivolumab (anti-PD-1) in advanced solid malignancies are underway (for example NCT01950390- Phase 2 stage III-IV melanoma; NCT01454102- Phase 1 stage IIIB/IV non-small cell lung cancer). A re-engineered version of bevacizumab with a different glycosylation profile (bevacizumab beta, ABP 215) is in Phase 3 clinical trial for metastatic non-small cell lung cancers (NSCLC), This trial, NCT01966003 is comparing bevacizumab beta vs. the original bevacizumab, Bevacizumab (Avastin®) is sometimes prescribed 'off-label' as a therapy for wet age-related macular degeneration (AMD), as an alternative to ranibizumab (Lucentis®) and aflibercept (Eylea®). SARS-CoV-2 and COVID-19: Bevacizumab has been entered into clinical trials in patients with COVID-19, to determine if suppression of vascular permeability will reduce pulmonary edema in severe/critical COVID-19 patients.

Summary of Clinical Use

Used as part of combination therapy for metastatic colorectal cancer and HER2-negative metastatic breast cancer. In August 2014 the US FDA granted additional approval for metastatic cervical cancer. In November 2014, FDA approval was extended to include a combination therapy of bevacizumab plus chemotherapy (paclitaxel, pegylated liposomal doxorubicin or topotecan) for platinum-resistant, recurrent ovarian cancer (based on findings from the Phase 3 AURELIA clinical trial NCT00976911). Additional Phase 2 clinical trial results are provided in [5]. In June 2018, FDA approval was further expanded to include the treatment of epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, in patients with stage III or IV disease, and to be used after initial surgical resection [2] [4].
Clinical trials evaluating bevacizumab in combination with the immune checkpoint inhibitors ipilimumab (anti-CTLA4) or nivolumab (anti-PD-1) in advanced solid malignancies are underway (for example NCT01950390- Phase 2 stage III-IV melanoma; NCT01454102- Phase 1 stage IIIB/IV non-small cell lung cancer).

A re-engineered version of bevacizumab with a different glycosylation profile (bevacizumab beta, ABP 215) is in Phase 3 clinical trial for metastatic non-small cell lung cancers (NSCLC), This trial, NCT01966003 is comparing bevacizumab beta vs. the original bevacizumab,
Bevacizumab (Avastin®) is sometimes prescribed 'off-label' as a therapy for wet age-related macular degeneration (AMD), as an alternative to ranibizumab (Lucentis®) and aflibercept (Eylea®).

SARS-CoV-2 and COVID-19: Bevacizumab has been entered into clinical trials in patients with COVID-19, to determine if suppression of vascular permeability will reduce pulmonary edema in severe/critical COVID-19 patients.

Mechanism Of Action and Pharmacodynamic Effects
A recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF) which reduces or prevents angiogenesis. The rationale behind anti-VEGF as an anti-angiogenic therapy is described in [3].

Mechanism Of Action and Pharmacodynamic Effects

A recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF) which reduces or prevents angiogenesis. The rationale behind anti-VEGF as an anti-angiogenic therapy is described in [3].

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT00976911	AURELIA: A Study of Avastin (Bevacizumab) Added to Chemotherapy in Patients With Platinum-resistant Ovarian Cancer	Phase 3 Interventional	Hoffmann-La Roche
NCT01454102	Study of Nivolumab (BMS-936558) in Combination With Gemcitabine/Cisplatin, Pemetrexed/Cisplatin, Carboplatin/Paclitaxel, Bevacizumab Maintenance, Erlotinib, Ipilimumab or as Monotherapy in Subjects With Stage IIIB/IV Non-small Cell Lung Cancer (NSCLC) (CheckMate 012)	Phase 1 Interventional	Bristol-Myers Squibb
NCT01950390	Ipilimumab With or Without Bevacizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery	Phase 2 Interventional	National Cancer Institute (NCI)
NCT01966003	Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer	Phase 3 Interventional	Amgen
NCT04275414	Bevacizumab in Severe or Critical Patients With COVID-19 Pneumonia	Phase 2/Phase 3 Interventional	Qilu Hospital of Shandong University	Bevacizumab is being evaluated as a mechanism to suppress vascular permeability and pulmonary edema in patients with severe/critical COVID-19. This anti-VEGF drug is predicted to reduce acute lung injury and acute respiratory distress syndrome (ARDS) in selected patients, and hopefully to reduce respiratory failure and death from COVID-19.
NCT04344782	Trial Evaluating Efficacy and Safety of Bevacizumab (Avastin®/Zeribev®) in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort	Phase 2 Interventional	Assistance Publique - Hôpitaux de Paris
NCT04305106	Bevacizumab in Severe or Critically Severe Patients With COVID-19 Pneumonia-RCT	N/A Interventional	Qilu Hospital of Shandong University

External links
For extended ADME data see the following: Electronic Medicines Compendium (eMC) Drugs.com European Medicines Agency (EMA)

External links

For extended ADME data see the following:

Electronic Medicines Compendium (eMC)
Drugs.com
European Medicines Agency (EMA)