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FDA Gives Avastin for Breast Cancer Thumbs Down

Nov 21, 2011 | Parker Waichman LLP

The U.S. Food & Drug Administration (FDA) announced its final decision to revoke Avastin's approval for breast cancer.   In announcing its decision, the FDA cited Avastin's serious side effects, and a lack of evidence showing Avastin will either help them victims of metastatic breast cancer live longer or improve their quality of life.

Avastin will remain on the market as a treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme).

“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. But patients must have confidence that the drugs they take are both safe and effective for their intended use,” Dr. Margaret Hamburg, FDA commissioner, said in a statement.

Because Avastin will remain on the market, doctors could continue to use it off-label as a treatment for metastatic breast cancer.  Whether insurers will still to cover the $80,000+/year bill for the drug remains to be seen.    Medicare, however, which covers many women with breast cancer, has already said it would continue to cover the cost regardless of the FDA's action.

Avastin was approved for metastatic breast cancer in February 2008 under the FDA’s accelerated approval program.  But two studies conducted by the drug's maker, Genentech, later showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone.   Serious complications from Avastin include bleeding and hemorrhage; the development of perforations in the intestines and other areas of the body; and heart attack or heart failure.

According to the Associated Press, breast cancer organization Susan G. Komen for the Cure said it respected the FDA decision and that it was time for researchers to focus on finding so-called biomarkers that would tell which drug is right for which patient.

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