Roche Appeals FDA Move Against Avastin

The FDA decided in December that Avastin was not an effective treatment for breast cancer and said it would take steps to revoke market approval and change the drug's label.

Swiss pharmaceutical giant Roche on June 28 began a two-day appeal asking the U.S. Food and Drug Administration to allow the top-selling drug Avastin to be used for breast cancer. The FDA decided in December that Avastin was not an effective treatment for breast cancer and said it would take steps to revoke market approval and change the drug's label.

The U.S. regulatory move followed the recommendation of an expert panel that said the drug, also known as bevacizumab, carries risks such as severe high blood pressure and hemorrhage and does not prolong overall survival in women suffering from breast cancer.

Avastin had been approved for treatment of advanced breast cancer under the FDA's accelerated approval program, which allows provisional approval of medicines for cancer or other life-threatening diseases.

The panel's recommendation did not affect the use of Avastin to treat other cancers, including colon and lung cancers.

Genentech, the Roche-owned U.S .pharmaceutical company that makes Avastin, released a statement last month detailing its arguments on why Avastin should stay on the market, which would be presented at the FDA hearing.

"When used with traditional chemotherapies, Avastin delays cancer progression and improves response," said the statement, which also offered lengthy arguments about how the clinical data should be interpreted.

Avastin remains FDA-approved for use in combination with the chemotherapy drug paclitaxel for first-line treatment of metastatic HER2-negative breast cancer until the hearing ends and FDA makes a final decision, the company said.

European medical experts have urged that the drug be restricted to use in combination with paclitaxel only instead of other forms of chemotherapy because benefits were uncertain.

Copyright Agence France-Presse, 2011

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