FDA Approves Xeloda/Taxotere Combination for Advanced Breast Cancer

ROCKVILLE, Maryland—The Food and Drug Administration (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 chemotherapy regimen.

Capecitabine, an oral cancer therapy, was initially approved as monotherapy for refractory metastatic breast cancer in 1998, the same year that docetaxel received approval for use in advanced breast cancer.

The approval of the combination was based on an open-label study of capecitabine in combination with docetaxel, compared with docetaxel alone conducted in 511 patients.

The study showed an improvement in response rates, time to worsening of disease, and survival in patients treated with the combination regimen.