Resources for Food and Drug Administration (FDA)

F.D.A. Criticizes Avastin Use for Breast Cancer

www.nytimes.com

Genentech’s drug Avastin did not help women with breast cancer live meaningfully longer, and it caused significant side effects, including a few deaths, the Food and Drug Administration said yesterday in a review of the drug.

The analysis by the agency’s staff appeared to dim the prospects that Avastin would win a approval as a treatment for breast cancer. Genentech’s stock fell $2.75, or 3.6 percent, yesterday, closing at $73.50.

An advisory committee to the F.D.A. will meet tomorrow to discuss whether Avastin, already a blockbuster drug for colon and lung cancer, will win an additional approval for breast cancer. The drug had $1.7 billion in United States sales in the first nine months of the year. Roche Holding, which owns a majority of Genentech, sells it overseas.

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