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Xeloda

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    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.

    Approval Date: 1998-04-01
    Date Created: 1998-05-04 12:00:00
    Company Name: Roche
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