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FDA advises withdrawal of Avastin approval

Advisers to the US Food and Drug Administration have recommended to withdraw approval of the metastatic breast cancer indication for Roche's Avastin as EU extends the drug's label

Advisers to the US Food and Drug Administration (FDA) have recommended to withdraw approval of the metastatic breast cancer indication for Roche's Avastin (bevacizumab).

The Oncologic Drugs Advisory Committee (ODAC) unanimously voted to halt the use of the drug in cases of breast cancer stating that the drug has not been shown to be safe and effective for the indication.

It has been suggested the withdrawal may affect Roche's annual sales by as much as $1bn by 2015. Avastin, which is also approved for the other indications of colorectal cancer, non-small cell lung cancer and kidney cancer, made CHF6.46bn (about $7.74bn) during 2010.

The decision backs a previous recommendation from the FDA in December, 2010 to withdraw Avastin's approval for breast cancer, which reviewed the results of four clinical studies of the drug in women with the disease and determined that the data indicated that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.

Side-effects of the drug include stroke, wound healing complications and organ damage or failure.

The final decision is still to be made by the FDA commissioner, and Roche are scheduled to provide additional written submissions by July 28, 2011, with public comment invited until that date.

"We are very disappointed by the committee's recommendation and hope the commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options," said Dr Hal Barron, chief medical officer and head, global product development at Roche. "We remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin."

In December, 2010, the UK's National Institute for Health and Clinical Excellence (NICE) recommended against the use of Avastin on the NHS for the treatment of metastatic breast cancer.

Also announced today was the EU's decision to expand the label of Avastin to allow the drug to be used in combination with Xeloda (capecitabine) as a first-line treatment.

The decision is based data from a phase III study which showed an increase in the length of time women lived without their disease getting worse when Avastin was combined with capecitabine, compared to those who received capecitabine alone.

30th June 2011

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