OK of breast cancer drug may clear way for change in standards
2/22/2008WASHINGTON A drug made by Genentech received federal approval on Friday to treat breast cancer, a decision that could represent a major shift in standards for assessing the effectiveness of cancer medicines.
Going against the recommendation of its advisory panel, the Food and Drug Administration cleared Genentech s Avastin, which is already approved for treating lung and colon cancer, based on findings that it slowed tumor growth.
The agency has traditionally approved drugs for late-stage cancer if they extended, or improved the quality of, patients lives. Avastin showed neither, according to Genentech s application.
Wall Street analysts believe FDA s Avastin decision opens the door for other cancer drugs to be approved for their tumor-shrinking capabilities a trend that worries some health experts.
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