Overview
There is a great deal of evidence indicating that vascular endothelial growth factor (VEGF) is important for the survival and proliferation of cancer cells. VEGF plays an important role in angiogenesis, lymphangiogenesis, and tumor growth, which are all factors that contribute to its attractiveness as a therapeutic target for anti-cancer therapies. In 2004, bevacizumab (Avastin) gained FDA approval for specific types of cancer, and became the first antiangiogenic agent introduced to the market. It is a humanized monoclonal IgG antibody, and inhibits angiogenesis by binding and neutralizing VEGF-A. Bevacizumab is generally indicated for use in combination with different chemotherapy regimens which are specific to the type, severity, and stage of cancer. Bevacizumab was approved by Health Canada on March 24, 2010 and by the European Commission on April 21, 2021. There are also biosimilars of bevacizumab available, such as bevacizumab-awwb, bevacizumab-maly, and bevacizumab-adcd. Interestingly, researchers have identified higher VEGF expression in patients with COVID-19, which may contribute to lung pathologies including acute respiratory syndrome (ARDS) and acute lung injury (ALI). As such, bevacizumab is being investigated for the treatment of lung complications associated with severe cases of COVID-19.
Background
There is a great deal of evidence indicating that vascular endothelial growth factor (VEGF) is important for the survival and proliferation of cancer cells. VEGF plays an important role in angiogenesis, lymphangiogenesis, and tumor growth, which are all factors that contribute to its attractiveness as a therapeutic target for anti-cancer therapies. In 2004, bevacizumab (Avastin) gained FDA approval for specific types of cancer, and became the first antiangiogenic agent introduced to the market. It is a humanized monoclonal IgG antibody, and inhibits angiogenesis by binding and neutralizing VEGF-A. Bevacizumab is generally indicated for use in combination with different chemotherapy regimens which are specific to the type, severity, and stage of cancer. Bevacizumab was approved by Health Canada on March 24, 2010 and by the European Commission on April 21, 2021. There are also biosimilars of bevacizumab available, such as bevacizumab-awwb, bevacizumab-maly, and bevacizumab-adcd. Interestingly, researchers have identified higher VEGF expression in patients with COVID-19, which may contribute to lung pathologies including acute respiratory syndrome (ARDS) and acute lung injury (ALI). As such, bevacizumab is being investigated for the treatment of lung complications associated with severe cases of COVID-19.
Indication
As a vascular endothelial growth factor (VEGF) inhibitor, bevacizumab is used in several chemotherapy regimens to treat metastatic colorectal cancer; metastatic, unresectable, locally advanced or recurrent non-squamous non-small cell lung cancer; metastatic renal cell carcinoma; metastatic, persistent, or recurrent cervical cancer; primary peritoneal cancer; epithelial ovarian cancer; fallopian tube cancer; breast cancer; and recurrent glioblastoma. Interestingly, bevacizumab is currently under investigation for the treatment of COVID-19 complications including acute respiratory distress syndrome (ARDS) and acute lung injury (ALI).
Associated Conditions
- Metastatic Breast Cancer
- Metastatic Cervical Cancer
- Metastatic Colorectal Cancer (CRC)
- Metastatic Non-squamous Non Small Cell Lung Cancer
- Metastatic Renal Cell Carcinoma ( mRCC)
- Persistent Cervical Cancer
- Recurrent Cervical Cancer
- Recurrent Glioblastoma
- Relapsed Glioblastoma
- Stage III Fallopian Tube Cancer
- Stage III Ovarian Epithelial Cancer
- Stage III Primary Peritoneal Cancer
- Stage IV Fallopian Tube Cancer
- Stage IV Ovarian Epithelial Cancer
- Stage IV Primary Peritoneal Cancer
- Locally advanced nonsquamous non-small cell lung cancer
- Recurrent Non-Squamous Non-Small Cell Lung Cancer
- Recurrent Platinum-Sensitive Epithelial Ovarian Cancer
- Recurrent Platinum-resistant Epithelial Ovarian Cancer
- Recurrent platinum drug resistant Fallopian tube cancer
- Recurrent platinum drug resistant primary peritoneal cancer
- Recurrent platinum sensitive primary peritoneal cancer
- Recurrent platinum-sensitive fallopian tube cancer
- Unresectable Non-Squamous Non-Small Cell Lung Cancer
- Unresectable, advanced Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC)
Research Report
Bevacizumab (DB00112): A Comprehensive Monograph on its Pharmacology, Clinical Efficacy, and Evolving Therapeutic Landscape
Section 1: Introduction to Bevacizumab: A First-in-Class Anti-Angiogenic Agent
1.1 Developmental History and Regulatory Milestones
Bevacizumab, marketed under the brand name Avastin® and its biosimilars, represents a landmark achievement in oncology, being the first anti-angiogenic agent to gain regulatory approval and enter the clinical armamentarium.[1] Its development was founded upon the pivotal discovery that tumor growth is an angiogenesis-dependent process. The scientific rationale posits that by inhibiting the formation of new blood vessels, a tumor's supply of oxygen and nutrients can be restricted, thereby arresting its growth and metastatic potential.[1] This therapeutic strategy targets a fundamental process of tumorigenesis rather than the cancer cells themselves.
The agent achieved its first major regulatory milestone on February 26, 2004, when the U.S. Food and Drug Administration (FDA) granted approval for its use in combination with chemotherapy for the first-line treatment of metastatic colorectal cancer (mCRC).[4] This approval heralded a new era of targeted therapy in oncology. Subsequently, bevacizumab received marketing authorisation from the European Medicines Agency (EMA) on January 12, 2005, and from Health Canada on March 24, 2010, solidifying its role as a global standard of care for various malignancies.[6] The drug's development was driven by a wealth of evidence indicating that vascular endothelial growth factor (VEGF), specifically VEGF-A, is a critical mediator of angiogenesis, lymphangiogenesis, and tumor proliferation, making it an exceptionally attractive therapeutic target.[1]
1.2 Biochemical Profile: A Humanized IgG1 Monoclonal Antibody
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/08 | Not Applicable | Not yet recruiting | |||
2025/06/17 | Phase 2 | Not yet recruiting | |||
2025/06/17 | Phase 3 | Not yet recruiting | |||
2025/06/15 | Phase 2 | Not yet recruiting | Sun Yat-sen University | ||
2025/06/10 | Phase 4 | Active, not recruiting | Kasr El Aini Hospital | ||
2025/06/10 | Phase 1 | Recruiting | Sun Yat-sen University | ||
2025/06/10 | Phase 2 | Not yet recruiting | |||
2025/06/09 | Phase 2 | Not yet recruiting | |||
2025/06/06 | Phase 2 | Not yet recruiting | Wuhan Union Hospital, China | ||
2025/06/06 | Phase 2 | Not yet recruiting | Qianfoshan Hospital |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Genentech, Inc. | 50242-060 | INTRAVENOUS | 100 mg in 4 mL | 9/23/2022 | |
| Amgen Inc | 55513-207 | INTRAVENOUS | 400 mg in 16 mL | 11/18/2021 | |
| CELLTRION USA, Inc. | 72606-012 | INTRAVENOUS | 400 mg in 16 mL | 2/22/2023 | |
| Genentech, Inc. | 50242-061 | INTRAVENOUS | 400 mg in 16 mL | 9/23/2022 | |
| Amneal Pharmaceuticals LLC | 70121-1755 | INTRAVENOUS | 400 mg in 16 mL | 4/23/2022 | |
| Amgen Inc | 55513-206 | INTRAVENOUS | 100 mg in 4 mL | 11/18/2021 | |
| CELLTRION USA, Inc. | 72606-011 | INTRAVENOUS | 100 mg in 4 mL | 2/22/2023 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0315 | INTRAVENOUS | 100 mg in 4 mL | 2/24/2023 | |
| Pfizer Laboratories Div Pfizer Inc | 0069-0342 | INTRAVENOUS | 400 mg in 16 mL | 2/24/2023 | |
| Amneal Pharmaceuticals LLC | 70121-1754 | INTRAVENOUS | 100 mg in 4 mL | 4/23/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/26/2021 | ||
Authorised | 8/17/2022 | ||
Authorised | 3/26/2021 | ||
Authorised | 4/21/2021 | ||
Authorised | 1/15/2018 | ||
Authorised | 7/26/2024 | ||
Authorised | 5/27/2024 | ||
Authorised | 1/12/2005 | ||
Withdrawn | 1/11/2021 | ||
Authorised | 8/19/2020 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ZIRABEV CONCENTRATE FOR SOLUTION FOR INFUSION 100 MG/4 ML | SIN16286P | INFUSION, SOLUTION CONCENTRATE | 100 mg/vial | 7/26/2021 | |
| MVASI CONCENTRATE FOR SOLUTION FOR INFUSION 25 MG/ML | SIN16151P | INFUSION, SOLUTION CONCENTRATE | 25 mg/mL | 4/10/2021 | |
| Avastin Concentrate for Solution for Infusion 100mg/4ml | SIN13065P | INFUSION, SOLUTION CONCENTRATE | 25mg | 3/16/2005 | |
| ABEVMY™ CONCENTRATE FOR SOLUTION FOR INFUSION 25MG/ML | SIN16583P | INJECTION, SOLUTION, CONCENTRATE | 25 mg/ml | 8/29/2022 | |
| ZIRABEV CONCENTRATE FOR SOLUTION FOR INFUSION 400 MG/16 ML | SIN16287P | INFUSION, SOLUTION CONCENTRATE | 400 mg/vial | 7/26/2021 | |
| Avastin Concentrate for Solution for Infusion 400mg/16ml | SIN14097P | INFUSION, SOLUTION CONCENTRATE | 400mg | 2/6/2012 | |
| VEGZELMA CONCENTRATE FOR SOLUTION FOR INFUSION 25 MG/ML | SIN16810P | INFUSION, SOLUTION CONCENTRATE | 25 mg/ml | 6/16/2023 | |
| AVAMAB Concentrate for Solution for Infusion 100mg/4mL | SIN17101P | INFUSION, SOLUTION CONCENTRATE | 100mg/4ml | 9/25/2024 | |
| AVAMAB Concentrate for Solution for Infusion 400mg/16mL | SIN17102P | INFUSION, SOLUTION CONCENTRATE | 400mg/16ml | 9/25/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Bevacizumab Injection | 国药准字S20250004 | 生物制品 | 注射剂 | 1/8/2025 | |
| Bevacizumab Injection | 国药准字S20240051 | 生物制品 | 注射剂 | 11/15/2024 | |
| Bevacizumab Injection | 国药准字S20210047 | 生物制品 | 注射剂 | 11/24/2021 | |
| Bevacizumab Injection | 国药准字SJ20170035 | 生物制品 | 注射剂 | 4/22/2022 | |
| Bevacizumab Injection | 国药准字S20210044 | 生物制品 | 注射剂 | 11/17/2021 | |
| Bevacizumab Injection | 国药准字S20210020 | 生物制品 | 注射剂 | 6/22/2021 | |
| Bevacizumab Injection | 国药准字S20233105 | 生物制品 | 注射剂 | 2/28/2023 | |
| Bevacizumab Injection | 国药准字S20210049 | 生物制品 | 注射剂 | 11/30/2021 | |
| Bevacizumab Injection | 国药准字S20200013 | 生物制品 | 注射剂 | 5/6/2023 | |
| Bevacizumab Injection | 国药准字S20210048 | 生物制品 | 注射剂 | 11/30/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| AVASTIN ROCHE CONCENTRATE FOR SOLN FOR INFUSION 100MG/4ML | N/A | N/A | N/A | 3/19/2010 | |
| AVASTIN ROCHE CONCENTRATE FOR SOLN FOR INFUSION 400MG/16ML | N/A | N/A | N/A | 3/19/2010 | |
| AVASTIN ROCHE INJ 400MG/16ML | N/A | N/A | N/A | 5/15/2008 | |
| AVASTIN ROCHE INJ 100MG/4ML | N/A | N/A | N/A | 5/15/2008 |