FDA Approves Aventis Cancer Drug for New Use

The U.S. Food and Drug Administration on Wednesday approved Aventis’s drug Taxotere for treating advanced prostate cancer.

Aventis, which is being acquired by Sanofi-Synthelabo, already sells Taxotere for fighting advanced lung and breast cancer. Taxotere is the first approved drug shown to help extend the lives of men whose prostate cancer does not respond to hormonal treatments, FDA regulators said in a statement. The FDA approved Taxotere, which is given by injection, for use with prednisone, a steroid. A clinical trial of more than 1,000 patients compared Taxotere plus prednisone to another combination, prednisone and the cancer drug mitoxantrone. Patients given the Taxotere combination survived about 2.5 months longer than the other patients, the FDA said. (Source: Reuters Health News: May 2004)