Roche files sNDA for Xeloda/Taxotere
Roche has submitted a supplemental New Drug Application to the US Foodand Drug Adminstration for its twice-daily oral chemotherapy Xeloda (capecitabine) in combination with Aventis' Taxotere (docetaxel) given by infusion, for treatment in women with locally advanced and/or metastatic breast cancer who were previously treated with anthracycline therapy.
The data submitted includes the results of a Phase III study comparing Xeloda in combination with Taxotere to treatment with the latter only. Women treated with the combination experienced a 25% decreased risk of death compared with those treated with Taxotere alone.
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