Xeloda has been granted approval under the FDA's accelerated approval program.
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 including diarrhea, nausea, and fatigue were manageable and reversible after discontinuation.
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