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FDA Revokes Avastin Breast Cancer Approval


November 18, 2011 – The FDA was withdrawn its approval of Avastin for the treatment of breast cancer, announced FDA commissioner Dr. Margaret Hamburg in her 69-page decision on Friday. “I did not come to this decision lightly,” she said. “Sometimes, despite the hopes of investigators, patients, industry and even the FDA itself, the results of rigorous testing can be disappointing.”

Avastin remains approved for treatment of other cancers, including colon, lung, kidney, and brain cancers.

The FDA announcement has been anticipated since Avastin failed Phase III clinical trial in 2009, showing a lack of survival benefit and high risk of severe side effects. Though the tumors showed a remarkable 18% increased response rate compared to chemotherapy alone, the overall survival rates were unchanged.

In addition to being no more effective than chemotherapy treatment, Avastin has serious side effects that include severe high blood pressure; bleeding and hemorrhaging; heart attack or heart failure; and the development of perforations in the nose, stomach, and intestines. The FDA has also issued safety warnings regarding ovarian failure, severe bleeding or other thromboembolic events, and deteriorating jaw.

Avastin is effective against a broad range of cancers. Initial research showed that patients with malignant colorectal cancer who took Avastin lived an average of five months longer than patients who only used chemotherapy. It was approved for metastatic colorectal cancer and lung cancer in 2006, breast cancer in 2008, brain cancer in 2009, and a form of kidney cancer in 2009.

Though an FDA advisory panel recommended against approving the drug for the treatment of breast cancer, Avastin was fast-tracked through the FDA approval process. Under this accelerated FDA approval process, promising drugs are made available for life-threatening diseases while clinical studies are ongoing. The FDA may revoke approval as clinical studies provide more information about the drug’s efficacy, risks, and benefits.

Avastin belongs to a new class of drugs that inhibits an enzyme necessary for the growth of new blood vessels. This essentially starves the tumors of the blood supply they need to grow. Avastin is the first FDA-approved drug to use this method, and its success has made it one of the most popular cancer drugs in history.

Now that the FDA has revoked its approval for breast cancer, health insurers may not continue to pay for it. Including infusion fees, a year of treatment can cost upwards of $100,000. This would be prohibitively expensive for many women already taking Avastin to treat their breast cancer. The FDA is not issuing a recall – doctors could still prescribe Avastin for breast cancer as an “off label” use. However, the FDA is recommending that women talk to their doctor about switching to another form of cancer treatment.

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