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FDA to Remove Breast Cancer From Avastin's Label


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FDA to Remove Breast Cancer From Avastin's Label

The FDA voted to remove labeling for Avastin as a treatment for breast cancer. The drug first was approved as treatment for the disease in 2008, and this move comes as one of the early steps in banning it as a therapy entirely.

Genetech, the drug's manufacturer, is asking the FDA for a hearing, claiming that to remove breast cancer from its labeling could eliminate it as an option for thousands of women in need of many choices, according to Emax Health.

The FDA is pursuing action against the manufacturer, because studies failed to show that the drug prolonged patients' survival rate and because it showed side effects including high blood pressure, heart attacks, heart failure, hemorrhage and the development of performations in the nose, stomach and intestines, according to BioWorld.

As a result, the federal agency is urging Genetech to conduct more studies. The company must respond to the FDA's notice of opportunity for a hearing within 15 days to dispute the recommendations. If granted a hearing, it will have an opportunity to present information about Avastin's effectiveness in breast cancer and its safety.