Avastin is a drug for treatment of cancer. It is an injectable medicine. It slows down the growth and spread of cancerous cells in the body. It is used for treatment of various types of cancers such as kidney cancer, colon cancer, rectum cancer, lung cancer and breast cancer. It is also used for treatment of a particular type of brain tumor. It is administered to the patients as a part of a cancer drugs combination. Doctors prescribe it for other purposes as well, which are not listed in medicine guide of this drug.
Avastin was approved in 2004 by U.S. Food and Drug Administration for treatment of colon cancer. Later it also got approval for treatment of lung cancer in 2006. FDA approved it for treatment of metastatic breast cancer in 2008. It was also approved by FDA for treatment of kidney cancer and brain tumors known as glioblastoma in 2009. Avastin blocks the protein, responsible for formation of blood vessels. It lead to stoppage of blood supply to the tumor as new blood vessels, which could feed these tumors are not formed. Thus it slows down the growth and spread of cancerous cells or tumors.
In 2010 FDA proposed withdrawal of Avastin for treatment of metastatic breast cancer. This proposal was a result of different studies did not confirm safety and efficacy of this drug in treatment of metastatic breast cancer. FDA concluded that it had not enough evidence of safety and efficacy of this drug in treatment of metastatic breast cancer.
In January 2011, Genentech, the manufacturer of Avastin requested for a Notice of Opportunity for a Hearing. FDA reviewed the use of Avastin for treatment of breast cancer. The use of Avastin for treatment of colon cancer, lung cancer, kidney cancer and brain cancers was not under this review. The hearing was also related to the use of Avastin for treatment of metastatic breast cancer.
The hearing on the Center for Drug Evaluation and Research’s proposal of withdrawal of Avastin for metastatic breast cancer indication was completed in June 2011. Both Genentech and Center for Drug Evaluation and Research were scheduled to provide additional written submissions by July 28, 2011. After this hearing they awaited for FDA Commissioner Margaret Hamburg’s final decision on Avastin’s use for metastatic breast cancer.
FDA Commissioner Margaret Hamburg came to a decision of revoking the FDA approval of Avastin for treatment of metastatic breast cancer. The commissioner concluded that Avastin (bevacizumab) has not been shown to provide a benefit in treatment of metastatic breast cancer. The use of Avastin for metastatic breast cancer indication was removed from the label of the drug.
Avastin will remain on the market for treatment of other approved cancers. After the accelerated approval of Avastin for breast cancer Genentech, submitted data from its two additional clinical trials. These clinical data did not show any significant improvement in patients of metastatic breast cancer after being treated with Avastin. Dr. Hamburg came to this decision after reviewing arguments and evidence presented at the hearing. She also considered briefs filed by both Center for Drug Evaluation and Research and Genentech, public comments and data from multiple clinical trials.
FDA asked oncologists currently using Avastin for treatment of metastatic breast cancer to use their medical judgment for deciding course of treatment for the patients. It suggested patients using this drug for treatment of metastatic breast cancer to consult their oncologist for deciding the course of treatment.
