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FDA Pulls Approval of Avastin for Treating Breast Cancer

The Federal Drug Administration has revoked approval of the the drug Avasin for use in breast cancer patients because it has not been shown to be safe and effective for that particular use.

However, Avastin (bevacizumab) will continue on the market as an approved treatment for certain types of cancer including brain, lung, colon and kidney cancer.

“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,” said FDA Commissioner Margaret A. Hamburg in a news release.

After reviewing the studies, Hamburg said it was clear that women who take Avastin for metastatic breast cancer risk life threatening side effects with no proof of the drug’s benefits.

The risks for Avastin include heart attack or heart failure; bleeding and hemorrhaging; severe high blood pressure; and the development of perforations in various parts of the body like the stomach, nose and intestines.

The FDA’s decision involves Avastin used in combination with the cancer drug paclitaxel for those patients who have not been treated with chemotherapy for their form of metastatic breast cancer known as HER2 negative. This indication must now be removed from any and all product labeling for Avastin.

This decision is based on an extensive record, including thousands of pages submitted to a public docket, collected data from several clinical trials and the record from a two-day hearing held in June, 2011.

The FDA approved Avastin for metastatic breast cancer in February 2008 under its accelerated approval program. That program offers approval of a drug based on data not sufficiently complete to allow full approval. It provides for patients earlier access to promising new drugs to treat serious or life-threatening illnesses or diseases while clinical trials are being conducted.

If clinical trials don’t justify continued approval of the drug or a specific drug indication, the FDA can revoke its approval. For Avastin, the accelerated approval was based on promising results from a study, mainly that it could offer more time from the beginning of treatment until the tumor grows or the death of the patient.

After its accelerated approval for breast cancer, Avastin’s sponsor, Genentech, conducted two more clinical trials and submitted the results to the FDA. But the results only showed a small impact on tumor growth without proof that patients lived longer or had an improved quality of life compared to being treated with only standard chemotherapy. That was not enough to counterbalance the drug’s safety risks.

FDA’s Center for Drug Evaluation and Research, which is responsible for the approval of this drug, ultimately decided the lastest results of the studies did not warrant continued approval. The FDA contacted Genentech and proposed withdrawal of the drug’s approval.

“FDA is committed to working with sponsors to bring promising cancer drugs to market as quickly as possible using tools like accelerated approval,” Dr. Hamburg said. “I encourage Genentech to consider additional studies to identify if there are select subgroups of women suffering from breast cancer who might benefit from this drug.”

For more on drug safety issues, see the library of articles by Daytona Beach medical malpractice attorney.

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