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Home » Drug Information » FDA Approved Drugs » 1998
Medical Areas: Endocrinology | Obstetrics/Gynecology (Women’s Health) | Oncology | Family Medicine

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Xeloda

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Roche
Approval Status: Approved April 1998
Treatment Area: breast cancer

General Information

Xeloda has been granted approval under the FDA's accelerated approval program.

Clinical Results

The approval of the Xeloda pill was based on a study involving 43 patients whose cancer no longer responded to conventional treatment. In that group, Xeloda appeared to help shrink tumors in 25% of patients.

In a larger study of 162 patients whose cancer was resistant to normal treatment, Roche reported that tumors shrank by half in almost 20%.

Side Effects

Side effects including diarrhea, nausea, and fatigue were manageable and reversible after discontinuation.