FDA Withdraws Approval Of Avastin For Use In Treating Metastatic Breast Cancer

The U.S. Food and Drug Administration (FDA) announced on November 18, 2011 that it was revoking its approval of Avastin (bevacizumab) for use in treating breast cancer (specifically, the use of Avastin in combination with the cancer drug paclitaxel for breast cancer patients suffering from a form of metastatic breast cancer known as HER2 negative who have not been treated with chemotherapy) after the FDA concluded that Avastin had not been shown to be safe and effective in metastatic breast cancer treatment. Nonetheless, Avastin remains on the market and approved for treatment of certain types of colon cancer, lung cancer, kidney cancer, and the brain cancer known as glioblastoma multiforme.

The FDA stated that its decision was based on studies that found that Avastin used in treating metastatic breast cancer did not delay tumor growth, did not help breast cancer patients live longer, and did not improve the quality of their lives and thus the benefits did not outweigh the potentially life-threatening side effects of using Avastin. The known possible side effects of Avastin include severe high blood pressure, bleeding, hemorrhaging, heart attack, heart failure, and the development of perforations in the nose, stomach, and intestines.

Avastin, which is manufactured by Genentech, had previously received the FDA’s accelerated approval for use in treating metastatic breast cancer in February 2008 (the FDA’s accelerated approval program provides patients earlier access to promising new drugs to treat serious or life-threatening medical conditions during the clinical trial process — Avastin was the first drug approved under the accelerated approval program). Drugs approved under the accelerated approval program nevertheless may have their approval revoked if the subsequent clinical trials do not justify the continued approval of the drug or the continued approval of the drug for a specific drug indication.

This is what happened with Avastin with regard to its previously accelerated approval for use in treating metastatic breast cancer. A study seemed to indicate that the use of Avastin in the treatment of metastatic breast cancer may provide a meaningful increase in the time between when treatment is started and when the tumor grows or the patient dies. Based on that study, the FDA approved the use of Avastin for metastatic breast cancer patients, under the accelerated approval process. After the accelerated approval, Genentech provided the FDA with the results of two subsequent clinical studies that the FDA concluded showed that Avastin had only a small effect on tumor growth without evidence that the patients who were treated with Avastin lived any longer or had a better quality of life compared to patients who took the standard chemotherapy alone, and that the small effect was not sufficient to outweigh the substantial risks associated with the use of Avastin.

Genentech disagreed with the FDA’s revocation of its approval of Avastin in treating metastatic breast cancer.


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This entry was posted on Monday, November 21st, 2011 at 11:24 am. Both comments and pings are currently closed.


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