Women with hard-to-treat breast cancer now have another option for managing their potentially life-threatening disease.
The oral treatment Xeloda (capecitabine) was approved April 30 for patients with advanced breast cancer for which no acceptable alternative treatments are available. Specifically, the drug is for patients whose tumors are resistant to Taxol (paclitaxel) with an anthracycline or for those who should not have anthracycline therapy.
Xeloda was granted accelerated approval, an early approval process applied to some drugs that are used to treat life-threatening conditions. In studies, the drug measurably shrank some patients' tumors. The most common side effects of Xeloda include diarrhea, nausea, vomiting, fatigue, painful inflammation of the mouth, and painful rash and swelling of the hands and feet.
As a condition of approval, FDA is requiring the manufacturer, Hoffmann-La Roche Inc., Newark, N.J., to conduct further studies of the drug's clinical benefits.
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