The following information is obtained from various newswires,
published medical journal articles, and medical conference presentations.
Company: Roche
Approval Status: Approved April 1998
Treatment for: 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.
