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FDA Panel Rejects Avastin For Breast Cancer

http://online.wsj.com/article/BT-CO-20071205-711567.html

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DOW JONES NEWSWIRES
December 5, 2007 2:38 p.m.

WASHINGTON (Dow Jones)--A U.S. Food and Drug Administration panel narrowly rejected a Genentech Inc. (DNA) drug Wednesday as a proposed treatment for advanced breast cancer.

The panel, on a 5 to 4 vote, said the data provided by the company was not sufficient to provide a favorable risk benefit analysis for Avastin. The FDA typically follows its panel's advice but is not required to do so.

Avastin is currently approved as a part of a treatment regimen for colon and non-small-cell lung cancer. The drug was Genentech's second best-selling drug in 2006 with sales of $1.7 billion.

Genentech is seeking FDA approval of Avastin as a breast-cancer treatment in combination with the chemotherapy drug paclitaxel in women with advanced breast cancer who previously haven't received chemotherapy.

Genentech shares recently traded down 9%, or $6.58, to $66.20 on volume of 20.3 million compared with average daily volume of 3.4 million.
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