FDA Revokes Approval of Avastin for Breast Cancer

Article date: November 18, 2011

By Stacy Simon

The US Food and Drug Administration (FDA) has revoked approval of the drug Avastin (bevacizumab) for breast cancer. The decision won’t affect the approval of Avastin for other cancers. It’s approved for treating colorectal, kidney, non-small cell lung cancers, and certain brain tumors.

The announcement comes after an FDA advisory panel voted to withdraw approval for Avastin after a 2-day hearing in June, concluding that the drug was not effective and caused dangerous side effects.

At that hearing, several women with breast cancer gave emotional presentations saying that Avastin had saved their lives, and begged the panel not to withdraw approval.

FDA Commissioner Margaret A. Hamburg, MD, said the decision was difficult because there is such a great need for effective treatments for metastatic breast cancer, which is breast cancer that has spread to other parts of the body. But she said the drug has not been shown to be safe and effective for that use.

“After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks,” Hamburg said in a statement. “Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.”

Avastin’s risks include severe high blood pressure; bleeding that can be severe; heart attack or heart failure; and the development of perforations (holes) in different parts of the body such as the nose, stomach, and intestines.

Len Lichtenfeld, MD, deputy chief medical officer of the American Cancer Society, said today’s decision will likely lead insurance companies to review their coverage of Avastin for breast cancer. "At the least, we would hope that insurers will continue to cover treatment with Avastin in those women with metastatic breast cancer who are currently on the drug and who are showing a benefit from its use."

Avastin was approved for metastatic breast cancer in February 2008 under the FDA’s accelerated approval program, which provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while more clinical trials are conducted to confirm the drug’s benefits.

In this case, after the accelerated approval, the drug’s manufacturer Genentech completed two additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on tumor growth and no evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone.

The FDA concluded that those benefits were not enough to outweigh the risks of taking Avastin and began the process that resulted in today’s decision to revoke the drug’s approval for breast cancer. Hamburg urged Genentech to conduct more studies to see if there are some specific groups of breast cancer patients who might benefit from Avastin.

Women who are taking Avastin for breast cancer should talk to their doctors about what to do. For more information about breast cancer treatment, see our detailed guide.

Reviewed by: Members of the ACS Medical Content Staff

ACS News Center stories are provided as a source of cancer-related news and are not intended to be used as press releases.