Genentech Fights FDA's Downgrade Of Avastin

Law360, New York (December 23, 2010, 7:23 PM EST) -- Genentech Inc. has announced that it plans to appeal the U.S. Food and Drug Administration's finding that the blockbuster cancer drug Avastin has not been proven safe and effective in treating breast cancer.

In a letter sent to the FDA on Thursday, the drug behemoth requested a hearing to dispute the FDA's Dec. 16 decision, saying withdrawal of its popular drug as an approved treatment for breast cancer is not justified.

Avastin, the company said, has shown “significantly improved” rates of progression-free survival for breast cancer...
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