FDA Advisory Panel Votes Against Avastin for Advanced Breast Cancer

Article date: July 20, 2010

By: Rebecca V. Snowden

An advisory panel to the Food and Drug Administration (FDA) voted overwhelmingly Tuesday to recommend withdrawing approval for bevacizumab (Avastin) as a treatment of advanced breast cancer. The move followed the release of new study results showing the drug did not bring a significant benefit to women with this disease. The FDA has not announced its decision on the drug’s approval for breast cancer, though the agency tends to follow panel recommendations.

Bevacizumab, made by Genentech, first received accelerated approval by the FDA as part of the treatment for metastatic breast cancer in 2008. That approval was based on data showing that compared to chemo alone, combining chemo with bevacizumab extended the time it took for the disease to progress. However, even in 2008, there were questions about whether the women taking Avastin lived longer or had a better quality of life. As part of the accelerated approval process, Genentech agreed to conduct further studies to help answer these questions.

This week’s vote doesn’t affect patients taking Avastin for the treatment of other cancers, such as colon cancer and glioblastoma.

New data

The advisory panel based its recommendation on results from 2 large clinical trials showing only a limited benefit to women taking the drug, especially given the significant increase in side effects compared to chemo alone.

“The benefits of taking bevacizumab were clearly less impressive—and the side effects considerable—compared to previous reports,” said Len Lichtenfeld, MD, American Cancer Society deputy chief medical officer.

In the first study, researchers compared overall survival of 736 women separated into 3 groups: one group got chemo alone, while the other groups got chemo plus different doses of bevacizumab. The data showed an increase of only about 3 weeks in time to progression for the groups getting bevacizumab. However, those women also experienced more serious side effects than the group that got chemo alone.

In the second study, a group of 1237 metastatic breast cancer patients received one of three different types of chemo, in combination with bevacizumab or placebo. Again, the data showed only a modest gain in the time it took for the tumor to resume growing, but also an uptick in adverse side effects in the group taking bevacizumab.

Serious side effects of taking Avastin can include bleeding/hemorrhage, high blood pressure, nose bleeds, blood clots in veins or arteries, holes (perforations) in the stomach or intestines, and wound-healing complications. More common but less serious side effects included headache, irritated nose, protein in the urine, taste alteration, dry skin, rectal bleeding, tear production disorder, and inflammation of the skin.

What to do if you’re taking Avastin

Lichtenfeld says women currently taking Avastin for the treatment of metastatic breast cancer should talk to their oncologists about what course of action they should take given the release of this new data, pending the decision from the FDA.

This week’s vote doesn’t affect patients taking Avastin for the treatment of other cancers.

“These studies and recommendations do not have any impact on the use of bevacizumab in the treatment of other forms of cancer where the FDA has given approval, such as colon cancer and lung cancer,” said Lichtenfeld. “This review applies only to the specific recommendation regarding the use of bevacizumab in the treatment of recurrent breast cancer.”

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.