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.