First Approval Of Roche's Xeloda For Breast Cancer

Roche's new orally-active anticancer drug Xeloda (capecitabine) has beenapproved in the USA for the treatment of metastatic breast cancer in patients who fail to respond to standard chemotherapy, including treatment with Bristol-Myers Squibb's Taxol (paclitaxel) and anthracyclines such as doxorubicin.

Xeloda was given priority review status at the FDA because no other therapies are available for breast cancer patients who relapse after Taxol and anthracycline.

A spokesman for the company said that Xeloda would be made available commercially in the USA by the end of the month. No details of pricing have been revealed as yet, he noted. Roche filed for approval of Xeloda with the FDA and the European Medicines Evaluation Agency last year (Marketletter November 10, 1997), and the dossier has also been submitted to the regulatory authorities in Switzerland, where a decision is expected in the next two to three weeks. Once EMEA approval is granted, Roche plans to file for approval elsewhere in the world.