Saturday, 18 September 2010 at 10:08, Reuters, Washington
US regulators have extended by three months a review of Roche Holding AG's blockbuster drug Avastin in breast cancer, the company said on Friday.n The Food and Drug Administration has made no decision on whether to revoke Avastin's approval for treating breast cancer patients as an advisory panel has recommended, the FDA and the company said.
Roche unit Genentech said it had submitted additional information to the FDA on two applications to expand Avastin's approved breast cancer uses to include combining the drug with other types of chemotherapy. The new information prompted the FDA to extend the review of those uses until Dec. 17, a Genentech statement said. An FDA advisory panel that met in July urged the agency to reject those applications and to remove the drug's current approval for breast cancer. There is no set timeline for an FDA ruling on whether to revoke the breast cancer approval, Genentech spokeswoman Charlotte Arnold said.
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