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Degarelix Approved for Advanced Prostate Cancer

MONDAY, Dec. 29 -- The injected drug degarelix has been approved by the U.S. Food and Drug Administration to treat advanced prostate cancer.

It belongs to a class of drugs called gonadotropin releasing hormone (GnRH) receptor inhibitors, which suppress the male hormone testosterone. Certain hormonal treatments for prostate cancer initiate a spurt in production of testosterone, which is believed to play a vital role in the growth of prostate cancer. Degarelix doesn't cause this, the agency said in a news release.

Prostate cancer is the second-leading cause of death among men in the United States, according to the American Cancer Society. For 2008, 186,320 men will be diagnosed with the disease and 28,660 will die from it, the ACS estimates.

In clinical testing, degarelix was compared to leuprolide, a drug used in hormonal treatment of prostate cancer. Degarelix suppressed testosterone production to levels seen in men who had had surgical removal of the testes, the agency said.

Frequently reported side effects of the drug included injection site reactions, hot flashes, weight gain, fatigue and an increase in certain liver enzymes.

Degarelix is produced for New Jersey-based Ferring Pharmaceuticals by the German drug maker Rentschler Biotechnologie.

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Posted: December 2008