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FDA Removes Breast Cancer Indication from Avastin Label

Updated Nov. 18, 2011

The U.S. Food and Drug Administration has revoked approval of Avastin (bevacizumab) to treat metastatic breast cancer after it was found to cause several severe and potentially fatal side effects, including heart failure. In addition to the side effects, the FDA said Avastin should no longer be used in breast cancer patients because there’s no proof it extends their lives.

Avastin will not be taken off the market, since it is also used to treat certain types of colon, lung, kidney and brain cancer, but the FDA ruling is expected to influence insurance coverage. Medicare says it will continue to cover Avastin while it evaluates whether a change is needed.

The agency made its initial recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. The risks include severe high blood pressure, bleeding and hemorrhage, the development of perforations in the body, including in the nose, stomach, and intestines and heart attack or heart failure.

Avastin, in combination with chemotherapy (paclitaxel), was approved in February 2008 under the FDA’s accelerated approval program, based on the results of a clinical trial known as “E2100.” Avastin has also been associated with several other serious side effects including the risk of stroke, wound healing complications, organ damage or failure and the development of a neurological condition called reversible posterior leukoencephalopathy syndrome (RPLS), characterized by high blood pressure, headaches, confusion, seizures and vision loss from swelling of the brain.

Read more about Avastin and the FDA’s decision.

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