News & AnalysisFDA

Once on 'Fast Track,' Avastin Now Derailed

Science  08 Jul 2011:
Vol. 333, Issue 6039, pp. 143-144
DOI: 10.1126/science.333.6039.143

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Summary

A unanimous vote last week by advisers to the U.S. Food and Drug Administration (FDA) is likely to sharply curtail access in America to the breast cancer drug Avastin, exposing deep rifts among patient advocates, researchers, and regulators over what kind of scientific backing a drug needs to remain in use. Avastin was approved for breast cancer under FDA's accelerated approval process, but when follow-up studies showed only a sliver of benefit and serious health risks, FDA announced that it was revoking its approval. Genentech, Avastin's maker, then sought a reversal, arguing that few treatments are available to women with metastatic breast cancer and that the drug's performance could vary depending on the chemotherapy drug with which it's paired. But FDA officials said Avastin's initial promise simply hasn't held up.

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