Avastin® (bevacizumab)
About Avastin
Avastin is a humanized monoclonal antibody currently indicated for first-line and second-line treatment of metastatic colorectal cancer (CRC), first-line treatment of advanced non-small cell lung cancer (NSCLC), second-line treatment of glioblastoma, first-line treatment of renal cell carcinoma (RCC) and first-line treatment of metastatic breast cancer. Because of its high efficacy across a number of cancers, Avastin is considered the “gold standard” of treatment for indications such as CRC. It is used in combination with chemotherapy. Avastin is being tested for numerous additional indications with high unmet medical needs, including ovarian cancer and prostate cancer. Avastin is marketed in the United States by Genentech, in Japan by Chugai and in the rest of the world by Roche.
How Avastin Works
Avastin inhibits the function of vascular endothelial growth factor (VEGF), which is known to stimulate angiogenesis, the process by which new blood vessels develop to nourish a tumor. Avastin has been shown to cause micro-vessel regression and inhibit vessel growth and neo-vascularization.
Current Indications
Avastin was approved for:
- Colorectal Cancer (CRC) – February 2004 for the first-line treatment of metastatic CRC in combination with intravenous 5-FU-based chemotherapy. It was approved in June 2006 for the second-line treatment of metastatic cancer of the colon or rectum in combination with intravenous 5-FU-based chemotherapy.
- Non-small Cell Lung Cancer (NSCLC) – October 2006 (2007 in the EU) for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC in combination with carboplatin and paclitaxel.
- Breast Cancer – February 2008 (2007 in the EU) for the first-line treatment of patients with HER2-negative metastatic breast cancer in combination with paclitaxel.
- Glioblastoma – May 2009 for people with glioblastoma with progressive disease following prior therapy. The new indication for Avastin was granted under the USFDA accelerated approval program that allows provisional approval of medicines for cancer or other life-threatening diseases. The effectiveness of Avastin for this aggressive form of brain cancer is based on an improvement in objective response rate from the BRAIN study (AVF3708g) and an NCI study (NCI 06-C-0064E). Roche filed an application in the EU in December 2008 for marketing authorization for Avastin as a therapy for patients with previously treated glioblastoma. The BRAIN study forms the basis of both US and European regulatory submissions.
- Renal Cell Carcinoma (RCC) – August 2009 for people with metastatic RCC, the most common type of kidney cancer. According to the American Cancer Society, kidney cancer is the eighth most commonly diagnosed cancer in the United States. The USFDA approval is based on data from the pivotal Phase 3 study (AVOREN) in patients with advanced, previously untreated metastatic renal cell carcinoma. Kidney cancer is the uncontrolled growth of cancerous cells that originate in the kidneys with no known cause. Nine out of ten people with kidney cancer have RCC.
Clinical Trials
- Adjuvant colon cancer
- Adjuvant HER2-negative breast cancer
- Adjuvant HER2-positive breast cancer
- Adjuvant non-small cell lung cancer
- Diffuse large B-cell lymphoma
- First-line advanced gastric cancer
- First-line HER2-negative metastatic breast cancer
- First-line HER2-positive metastatic breast cancer
- First-line metastatic ovarian cancer
- Gastrointestinal stromal tumors
- High risk carcinoid
- Hormone refractory prostate cancer
- Newly diagnosed glioblastoma multiforme
- Relapsed platinum-sensitive ovarian cancer
- Second-line HER2-negative metastatic breast cancer
- Second-line Metastatic Colorectal Cancer