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Breast Cancer Drug Gets FDA Clearance

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The Associated Press

Published: February 23, 2008

WASHINGTON - A drug made by Genentech received federal approval 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, based on findings that it slowed tumor growth, cleared Genentech's Avastin, which is approved for treating lung and colon cancer.

Advocates for breast cancer patients applauded the ruling.
Genentech said the FDA granted the drug preliminary approval and the company will have to submit additional data.
FDA approval for late-stage cancer treatments is usually contingent upon data showing a drug extended or improved the quality of patients' lives. Avastin showed neither in a study, according to Genentech's application.

Instead, Genentech showed that the drug slowed tumor growth, without actually increasing life expectancy. Cancer experts have long debated whether that measure is as significant as survival rates for measuring a drug's effectiveness.

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