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U.S. Department of Health and Human Services

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Commissioner's Opening Statement from Media Call

Today I’m revoking FDA’s approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.

As a doctor, as a woman, and as a parent, I recognize how frightening and difficult it is to receive the diagnosis of metastatic breast cancer and to begin preparing for what may be very trying times ahead. Selecting a treatment option is one of the most daunting and important challenges patients face.

With so much at stake, patients and their doctors count on FDA to assure that the drugs they choose have been demonstrated to be safe and effective for their intended use by rigorous, objective, scientific testing.

Sometimes, despite the hopes of investigators, patients, industry, and even the FDA itself, the results of rigorous testing can be disappointing.  This is the case with Avastin when used for the treatment of metastatic breast cancer. That’s why today I am withdrawing the breast cancer indication from the product’s label. I did not come to this decision lightly but as a result of a rigorous process set up to ensure impartiality and a thorough analysis of this issue.

Avastin was approved to treat metastatic breast cancer in 2008 under an accelerated approval pathway. Accelerated approval is a regulatory tool that FDA uses to get promising drugs to patients quickly and may be granted when there is some evidence that the benefits of a drug may justify its risks, even though there are still unanswered questions that require additional study.  To remain on the market, products approved under this pathway must be further studied to demonstrate that they do indeed work and provide overall benefits to patients. The drug’s sponsor, Genentech, completed two additional clinical trials and submitted the data from those studies to the FDA.

Unfortunately, the additional studies failed to confirm Avastin’s initial promise so FDA’s Center for Drug Evaluation and Research, which is responsible for the approval of this drug, concluded that the results of these additional studies did not justify continued approval and proposed withdrawing the indication. Genentech did not agree with the Center’s evaluation of the data and, following the procedures set out in FDA regulations, requested a hearing on the Center’s withdrawal proposal, with a final decision to be made by me.

Women who take Avastin for metastatic breast cancer risk potentially life-threatening or serious side effects, such as heart attack or heart failure; severe high blood pressure; bleeding and hemorrhaging; and the development of perforations in different parts of the body such as the nose, stomach and intestines. These are the considerable risks of taking Avastin and can be justified only if there is good evidence that the use of the drug will benefit the patient. For some kinds of cancers, Avastin has been shown, by rigorous scientific testing, to provide a benefit that justifies its risks.  After reviewing the available breast cancer studies, however, it is clear there is no proof of a benefit in breast cancer patients that would justify those risks -- Avastin was not shown to provide a benefit, in terms of delay in tumor growth, that would justify its risks -- nor did it help women with breast cancer live longer or improve their quality of life.

Today’s decision will not affect other indications for Avastin. That is, Avastin will still be approved to treat patients for certain types of colon, lung, kidney, and brain cancer.
FDA doesn’t regulate the practice of medicine -- so any final decision on whether to use Avastin for metastatic breast cancer is up to a patient and their doctor. But I urge women who are currently taking the drug for breast cancer to discuss the risks and benefits of this drug with their oncologist.

There is still a great need for additional treatment options for metastatic breast cancer. I can assure you that FDA’s dedicated doctors and scientists are committed to working with Genentech and other drug developers to bring promising cancer therapies to patients as soon as possible.

Thank you and I will be happy to take your questions.


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