ROCKVILLE, MarylandThe 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
in combination with docetaxel, compared with docetaxel alone conducted in 511
The study showed an improvement in response rates, time to worsening of
disease, and survival in patients treated with the combination regimen.