FDA Allows Access to New Breast Cancer Drug

The Food and Drug Administration determined that women should have access to a new breast cancer pill called Xeloda while the manufacturer, Hoffman-La Roche, attempts to prove its capabilities. FDA advisers claimed that the drug should be available to women for whom alternative methods of treatment do not prove effective.

Xeloda, known as capecitabine, is a pill that is converted by the body into the drug 5FU when it reaches a tumor. In a study of 162 patients who were resistant to Taxol, the leading breast cancer drug, 20 percent reported that their tumors shrank to half their original size. A separate study of 43 patients who were resistant to Taxol and anthracyclines, another popular treatment, 25 percent of the patients reported improvement.

The FDA usually requires drug companies to prove that their drugs will offer “clinical benefit” and better quality of life. The side effects of the drug are diarrhea and numb and swollen feet hands.

Approximately 44,000 women die each year from breast cancer.


AP - March 20, 1998

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