FDA-Approved Drugs

The following drugs have been approved since the year 2000 for the treatment of prostate cancer:

Histrelin implant (histrelin acetate)

FDA approved October 2004

This drug is approved for the palliative treatment of advanced prostate cancer.

Taxotere (docetaxel)

FDA approved May 2004

Injecting this drug in combination with prednisone (a steroid), is approved for the treatment of patients with advanced metastatic prostate cancer. This is the first drug approved for hormone refractory prostate cancer that has shown a survival benefit.

Prostate cancer is the second leading cause of cancer death in men and for those patients who have not responded to hormone therapy, Taxotere, in combination with prednisone, is a new treatment option that has now shown a survival advantage.

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

The safety and effectiveness of Taxotere was established in a randomized, multi-center global clinical trial with over 1,000 patients comparing chemotherapy with taxotere and prednisone with mitoxantrone and prednisone in men with metastatic, hormone-refractory prostate cancer. Taxotere, in combination with prednisone, given every three weeks, showed a survival advantage of approximately 2.5 months over the control group in the trial.

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

Plenaxis depot (abarelix)

FDA approved November 2003

This drug is approved for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia.

Eligard (leuprolide acetate)

FDA approved  January 2002

This drug is approved for the palliative treatment of advanced prostate cancer.