Xeloda/Taxotere breast cancer therapy gets FDA endorsement

Drug Store News, Oct 8, 2001

The Food and Drug Administration approved a combination cancer therapy using the oral drug Xeloda (capecitabine) from Roche and the intravenous drug Taxotere (docetaxel) from Aventis. The combination is intended for patients with metastatic breast cancer whose cancer has progressed after treatment with an anthracycline-containing cancer therapy, such as adriamycin and doxorubicin.

Xeloda has been on the market for 13 years, Taxotere for five. Approval for the combination therapy was based on an open label study of Xeloda in combination with Taxotere, compared with Taxotere alone 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. Side effects are similar to those of other chemotherapy agents, with Xeloda capable of having a significant drug interaction with oral coumarin-derivative anticoagulant therapy, such as Coumadin.