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Avastin to lose breast cancer indication

The US Food and Drug Administration is to recommend removal of the breast cancer indication from the label of Genentech's Avastin

The US Food and Drug Administration (FDA) has announced that it is recommending removal of the breast cancer indication from the label of Genentech's Avastin (bevacizumab) after reviewing the results of four clinical studies of the drug.

The FDA's review found that the "significant" risks of the drug were not outweighed by its benefits, in that the drug failed to prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression. The risks of the drug include severe high blood pressure; bleeding and haemorrhage; the development of perforations in the nose, stomach, and intestines; and heart attack.

The FDA's decision comes after an advisory committee voted overwhelmingly earlier this year to remove the breast cancer indication.  

The FDA said that the removal of the breast cancer indication will be "a process" and stressed that the drug itself, which is approved for a number of cancer indications, is not being pulled from the market. The agency also said it is encouraging the company to "conduct additional research to identify if there may be select groups of patients who might benefit from this drug."

Genentech said it will request a hearing in order to oppose the FDA's decision. The company stressed that in Europe, the European Medicines Agency (EMA) has recently confirmed that Avastin in combination with paclitaxel helps women with metastatic breast cancer live longer and that the product's benefits outweigh its risks.

Avastin won accelerated US approval for the breast cancer indication in 2008 despite the fact that an advisory committee had recommended against marketing clearance of the drug for the use in a 5-4 vote.

20th December 2010


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