The Food and Drug Administration has approved an immune therapy against prostate cancer, a major breakthrough that will extend the lives of many advanced-stage prostate cancer patients.

Dendreon, the company that manufactures the activated immune therapy called Provenge, says only a few patients will be able to get the treatment in the next 12 months while manufacturing gets up to full speed. The treatment will be available at the University of Colorado Hospital.

"Years of research have provided evidence that the immune system fights cancer, but this is the first time an immune-therapy approach has received FDA approval with a large-scale clinical trial," said L. Michael Glodé, Robert Rifkin chair of prostate cancer research at the University of Colorado School of Medicine and associate director of the outreach program at the University of Colorado Cancer Center. "Unfortunately, the availability of the therapy will be limited at first while the company opens new manufacturing facilities. Initially, we expect to treat one to three patients a month. The issues with the manufacturer should be resolved in about a year."

Provenge trains the body's immune system to attack cancer cells. The therapy involves removing white blood cells from the patient through a process called apheresis and then mixing the cells with a drug designed to stimulate the emergence of target specific cancer cells. The treated blood is then infused back into the patient. A large number of patients involved in the research that lead to the approval of this immune therapy have been treated at University of Colorado Hospital.

"This vaccine could form the basis for optimism that we can finally develop better immunologic treatments for common cancers, including prostate cancer," said Thomas Flaig, M.D., assistant professor in medical oncology at the University of Colorado School of Medicine and member of the therapeutic development program at the University of Colorado Cancer Center. During clinical trials, the therapy extended the lives of advanced stage prostate cancer patients who have progressed despite hormone therapy by a median of four months. Three-year survival rates are also better in those who received Provenge in the clinical trial compared with those receiving the placebo.

More than 192,000 men are diagnosed with prostate cancer each year; 27,000 of them die. Prostate cancer is the third most common cause of death from cancer in men of all ages and is the most common cause of death from cancer in men over age 75. It is rarely found in men younger than 40.

Provenge will be available at University of Colorado Hospital. For more information about the innovative immune therapy, call 720-848-4500 or go to www.uch.edu/provenge.