The Wall Street Journal-20080213-Study May Help Effort to Widen Avastin Use

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Study May Help Effort to Widen Avastin Use

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Genentech Inc. said a study showed that its cancer drug Avastin slowed the growth of breast-cancer tumors when given in combination with chemotherapy, possibly strengthening the biotech company's bid for regulatory approval in this new market. The study -- the second of its kind -- was sponsored by Genentech's majority shareholder, Roche Holding AG.

Avastin, already approved for use in the treatment of colorectal and lung cancer, is facing a Feb. 23 decision by federal regulators on Genentech's application for extending its label and marketing the drug for breast cancer. Avastin fetched $2.3 billion in sales in 2007; analysts say an expanded label could significantly boost sales.

Genentech has faced an uphill battle in its quest to expand Avastin's label into the market for metastatic, or spreading, breast cancer, a diagnosis affecting nearly 40,000 women a year in the U.S.

Genentech, of South San Francisco, Calif., submitted to the Food and Drug Administration the results of an earlier trial sponsored by an independent cancer-cooperative group affiliated with the National Cancer Institute. In that study of 722 women, Avastin, when given with the drug Taxol, seemed to arrest cancer progression by an average 11.3 months, 5.5 months longer than did Taxol alone. But Avastin didn't significantly improve women's overall survival better than Taxol alone. Moreover, women taking Avastin suffered more severe side effects such as hypertension, blood clots and bowel perforation. There were also more deaths attributed to the Genentech drug.

As a result, an FDA advisory panel in December voted 5-4 against recommending that the agency approve marketing the drug for breast cancer. Women can already take the drug "off-label" if it is prescribed by an oncologist.