Docetaxel

The FDA has approved Taxotere (docetaxel) injection in combination with prednisone (a steroid) for treating men with advanced prostate cancer that no longer responds to hormone therapy (hormone refractory prostate cancer). Taxotere is the first drug approved to treat prostate cancer that has shown it can help extend a man's life.

"We consider this approval an important advance in the treatment of prostate cancer because it can help some patients live longer," Dr. Lester M. Crawford, Acting FDA Commissioner, said in announcing the approval in May 2004. "Patients need as many effective treatment options as possible, and Taxotere, in combination with prednisone, offers hope to certain patients who have not responded to other treatments."

Taxotere works by inhibiting tubulin, a protein essential to cell division, thus preventing cancer cells from dividing and growing in number.

Treatment with Taxotere and prednisone was compared with treatment with the cancer drug mitoxantrone and prednisone in a clinical trial involving more than 1,000 men with hormone refractory prostate cancer that had spread beyond the prostate gland. The men given Taxotere every three weeks lived about 2.5 months longer than the men given mitoxantrone every three weeks. Both groups received prednisone twice a day on a continuous basis.

The most common side effects reported were nausea, hair loss (alopecia), and bone marrow suppression. In addition, fluid retention and tingling sensations in the extremities (peripheral neuropathy), known effects of Taxotere, also were seen.

Prostate cancer is the second leading cause of cancer death in men. The American Cancer Society estimates there will be about 230,900 new cases of prostate cancer in the United States in 2004. About 29,900 men will die of the disease this year alone.

Taxotere is distributed by Aventis Pharmaceuticals Inc. of Bridgewater, N.J.

COPYRIGHT 2004 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group