Bevacizumab (trade name Avastin, Genentech/Roche) is a drug that blocks angiogenesis, the growth of new blood vessels. It is commonly used to treat various cancers, including colorectal, lung, breast, kidney, and glioblastomas.
Bevacizumab is a humanized monoclonal antibody that inhibits vascular endothelial growth factor A (VEGF-A). VEGF-A is a chemical signal that stimulates angiogenesis in a variety of diseases, especially in cancer. Bevacizumab was the first clinically available angiogenesis inhibitor in the United States.
Bevacizumab was approved by the U.S. Food and Drug Administration (FDA) for certain metastatic cancers. It received its first approval in 2004 for combination use with standard chemotherapy for metastatic colon cancer. While at one point approved for breast cancer by the FDA, the approval was revoked on 18 November 2011.
The approval for breast cancer was controversial, because although there was evidence that it slowed progression of metastatic breast cancer, there was no evidence that it extended life, or improved quality of life, and it caused adverse effects including severe high blood pressure and hemorrhaging. In 2008, the FDA gave bevacizumab provisional approval for metastatic breast cancer, subject to further studies. The FDA's advisory panel had recommended against approval. In July 2010, after new studies, the FDA's advisory panel again recommended against the indication for advanced breast cancer. Genentech requested a hearing, which was granted in June 2011. The FDA finally ruled to withdraw the breast cancer indication in November 2011. FDA approval is only required for Genentech to market a drug for that indication. Doctors can still prescribe it for that indication, although insurance companies are less likely to pay for it.
The drug is still approved for use in Australia.
In the curative setting (adjuvant therapy), clinical studies are still underway in breast cancer and lung cancer. A study released in April 2009 found that bevacizumab is not effective at preventing recurrences of non-metastatic colon cancer following surgery. In May 2009, it received FDA approval for treatment of recurring glioblastoma multiforme, while treatment for initial growth is still in phase III clinical trial.