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, EMA 2024)	Approved for use in the treatment of advanced lung and colorectal cancers
bevacizumab-vikg; ONS-5010	Lytenava	Outlook Therapeutics	Approved (EMA 2024)	To treat neovascular (wet) age-related macular degeneration (nAMD)

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)