FDA Defies Panel, OKs Avastin for Breast Cancer

In a rare move, the FDA goes against a panel recommendation on Avastin.

ByABC News
February 6, 2009, 8:11 PM

Feb. 22, 2008— -- WASHINGTON (AP) - A drug made by Genentech received federalapproval on Friday to treat breast cancer, a decision that couldrepresent a major shift in standards for assessing theeffectiveness of cancer medicines.

Going against the recommendation of its advisory panel, the Foodand Drug Administration cleared Genentech's Avastin, which isalready approved for treating lung and colon cancer, based onfindings that it slowed tumor growth.

The agency has traditionally approved drugs for late-stagecancer if they extended, or improved the quality of, patients'lives. Avastin showed neither, according to Genentech'sapplication.

Wall Street analysts believe FDA's Avastin decision opens thedoor for other cancer drugs to be approved for theirtumor-shrinking capabilities - a trend that worries some healthexperts.

(Copyright 2008 by The Associated Press. All Rights Reserved.)