TRENTON, N.J. (AP) -- The Food and Drug Administration approved Monday the combination of two existing drugs for use in women whose advanced breast cancer has not responded to standard medication.
Used together, Xeloda and Taxotere increased survival about 25 percent compared with Taxotere alone, according to a study of 511 women with advanced breast cancer for whom first-line drugs had failed.
Breast cancer is the No. 2 cancer killer of women in the United States.
''It's a small development but an important one,'' because the drug combination likely will help some women with no other options, said Joann Schellenbach, spokeswoman for the American Cancer Society.
Taxotere is administered intravenously every three weeks. Xeloda, a pill taken daily, won accelerated approval from the FDA in April 1998 because doctors had little to offer women whose breast cancer had spread despite surgery, radiation and treatment with standard breast cancer medications.
At the time, the FDA directed that the two drugs be tested together.
Xeloda interferes with a crucial step in cell division, while Taxotere disrupts ''machinery'' in cells needed for division. Cancer cells, which divide more rapidly than healthy ones, are more susceptible to such an attack.
Xeloda's maker, the Roche Group, parent of Nutley-based Hoffmann-La Roche Inc., funded the study. It found the increased median survival of the patients from 11 1/2 months for those getting Taxotere alone to 14 1/2 months for patients receiving both drugs.
Nearly 192,000 American women are diagnosed with breast cancer each year, and about 40,000 are expected to die from it this year, according to the cancer society.
Like other cancer treatments, the new combination can cause serious side effects. According to the FDA, those include fatigue, nausea, vomiting, diarrhea, painful swelling of the hands and feet, and suppression of bone marrow, which makes all the cells in blood. The drugs also must be used cautiously in women using blood-thinning medications.
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