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FDA reverses approval for Avastin in breast cancer

Side effects outweigh any positive benefits of Roche’s drug according to US regulator

The US Food and Drug Administration (FDA) has revoked approval for Roche's Avastin (bevacizumab) in the treatment of advanced breast cancer on the grounds that its benefits are modest and outweighed by its side effects.

On Friday, the FDA said it decided to pull its approval for Avastin in breast cancer after concluding that the drug had not been shown to be safe and effective for that use. The drug will remain on the market for other indications, including colon, lung and kidney cancer and glioblastoma, a form of brain tumour.

The news was not wholly unexpected, given that an FDA advisory panel voted 12-1 to reverse Avastin's approval in metastatic breast cancer in July, but has been criticised by some doctors who feel the drug is of benefit in some patients. It will now only be an option for those able to pay for the cost of therapy, running at several thousands of dollars a month.

Avastin's role in breast cancer has been in question since data emerged suggesting that its benefits were small - and in some cases may lead to a reduction in overall survival - when used in combination with other anticancer drugs such as paclitaxel, docetaxel and capecitabine.

"After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit," commented FDA Commissioner Margaret Hamburg in a statement to explain the decision.

Avastin's risks include severe high blood pressure, bleeding complications, heart attack or heart failure, and the development of perforations in different parts of the body such as the nose, stomach, and intestines, according to the FDA.

Roche has said it is disappointed with the decision and plans to carry out additional studies to try to identify subgroups of advanced breast cancer patients who may benefit from treatment with Avastin. In particular the company wants to focus on the combination of Avastin with paclitaxel in previously-untreated metastatic breast cancer patients. It may also appeal the FDA's decision.

Last year, the European Medicines Agency (EMA) concluded that Avastin still had a role to play when used in combination with paclitaxel in breast cancer patients, although it recommended against its use alongside docetaxel and capecitabine.

It remains to be seen whether other regulatory authorities will now take the FDA's lead. The EMA said it would continue to adhere to the verdict of its earlier investigation into Avastin, while Taiwan said it was carrying out its own review of the drug.

Roche said in a statement that Avastin is still approved for metastatic breast cancer in more than 80 countries. Sales of the product reached $3.9bn in the first nine months of 2011, a decline of 8 per cent which the company attributed in part to the uncertainty around the metastatic breast cancer indication in the US.

21st November 2011

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