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FDA approves the injectable drug ...

Posted Jan 11 2009 3:48pm
FDA approves the injectable drug degarelix as the newest hormonal therapy to treat prostate cancer

11 jan 2009-- Degarelix was recently approved by the U.S. Food and Drug Administration for the treatment of advanced prostate cancer, making it the first new drug approved for this indication in the past several years, according to a Dec. 29 FDA news release.

Degarelix, administered by injection, is a member of a class of drugs that inhibit the gonadotropin releasing hormone (GnRH) receptor. The consequence of degarelix-mediated GnRH inhibition is suppression of the production of testosterone. This hormone is important for the growth and survival of prostate cancer. Unlike traditional GnRH inhibitors, degarelix does not provoke an initial surge of testosterone prior to its suppression. This testosterone surge is thought to contribute to temporary growth of the prostate tumor.

The efficacy of degarelix was established in a clinical trial in which it was compared with the existing hormonal therapy leuprolide. Both drugs effectively lowered testosterone levels to those typically observed with surgical castration. The most frequently reported adverse events reported during the study were injection site reactions (such as pain, redness and swelling), hot flashes, weight gain, fatigue and increased liver enzyme levels.

"Prostate cancer is the second leading cause of cancer death among men in the United States and there is an ongoing need for additional treatment options for these patients," states Richard Pazdur, M.D., the director of the Office of Oncology Drug Products in the Center for Drug Evaluation and Research at the FDA.

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