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FDA Approves Xeloda in Combination with Taxotere for
Advanced Breast Cancer

FDA has approved a combination of the cancer drugs Xeloda (capecitabine) and Taxotere (docetaxel) for treating patients with metastatic breast cancer whose cancer has progressed after treatment with an anthracycline-containing cancer therapy (such as Adriamycin and doxorubicin).

Xeloda, an oral cancer therapy was initially approved for breast cancer on April 30, 1998. Docetaxel (Taxotere) an intravenous product was approved for treating advanced breast cancer on May 15, l998.

Today's approval was based on an open label study of Xeloda in combination with Taxotere compared to Taxotere alone conducted in 511 patients. The study demonstrated an improvement in response rates, time to worsening of disease, and survival in patients treated with the Xeloda/Taxotere combination.

Xeloda was originally approved under the accelerated approval program that allows early marketing of products for serious or life-threatening illnesses based on "surrogate endpoints". Today's approval is based on actual patient benefit as shown in the clinical trial.

Xeloda and Taxotere, like many cancer drugs, are associated with side effects including gastrointestinal symptoms such as diarrhea, nausea, vomiting, painful inflammation of the mouth, fatigue, hand-foot syndrome characterized by a painful swelling or redness of the hands or feet, and bone marrow suppression. Patients should be made aware of the side effects associated with Xeloda/Taxotere treatment. Side effects should be managed with appropriate medical intervention that may include dose reduction or interruption, or discontinuation of treatment. Details regarding dose modifications for renal impairment can be found in the package insert.

Xeloda also has a significant drug interaction with oral coumarin-derivative anticoagulant therapy (e.g., Coumadin) which can result in serious bleeding complications. Patients receiving Xeloda and a coumarin-derivative should have their anticoagulant response monitored frequently. The boxed warning in the package insert provides additional information.

Xeloda is manufactured by Roche. Taxotere is marketed by Aventis, Inc.

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