Avastin Breast Cancer Approval Revoked by FDA Despite Roche Appeal

Avastin’s federal approval for the treatment of breast cancer has been revoked; a decision likely to lead insurance companies to no longer cover the expensive drug’s use. 

FDA Commissioner Margaret Hamburg announced on November 18 that Avastin is no longer approved in the United States for treatment of breast cancer. However, an Avastin recall will not be issued, since it remains approved for the treatment of a number of different types of cancer, including colon, lung and kidney cancer.

The decision was expected and came following an attempt by Roche, the manufacturer, to appeal the initial revocation the FDA made in December 2010. An FDA advisory committee voted in agreement with the decision in June.

“This was a difficult decision. FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments,” Hamburg said in a press release. “But patients must have confidence that the drugs they take are both safe and effective for their intended use.”

Avastin (bevacizumab) was approved by the FDA in 2004 for treatment of non-small cell lung cancer and colorectal cancer when combined with chemotherapy. It was then was granted accelerated approval for use with paclitaxel to treat breast cancer patients by FDA in February 2008. The drug prevents the formation of new blood vessels in tumors, starving them and inhibiting their growth.

The approval of Avastin for breast cancer treatment was based on a clinical trial finding that it slowed the growth of breast cancer tumors, at odds with the usual requirement that breast cancer treatment drugs show that they actually extend the lives of patients. As part of the accelerated approval process, Genentech, a subsidiary of Roche, had to continue two more drug trials and then submit their findings to FDA.

FDA drug safety investigators say that those studies have failed to show that Avastin prolongs the life of breast cancer patients or improves their quality of life, despite a large number of anecdotal stories from breast cancer patients that used and believe in the drug.

In addition to failing to show any actual benefits, Avastin side effects can include severe high blood pressure, bleeding, hemorrhaging, heart attacks, heart failure and the drug has also been linked to the development of perforations in the nose, intestines and stomach. 

Despite the FDA’s revocation of its approval for breast cancer treatment, doctors can still prescribe Avastin to breast cancer patients “off-label.” However, the FDA’s move is likely to lead insurance companies to decide not to cover Avastin for breast cancer use, effectively placing the $88,000-a-year drug financially out of reach for most patients.