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FDA Approves Prostate Cancer Drug, Degarelix

-December 29, 2008

Recently, the Food and Drug Administration (FDA) approved a new injectable drug, known as degarelix, for use in the treatment of prostate cancer.

Produced by the New Jersey-based Ferring Pharmaceutials Inc., degarelix is the first new medication for prostate cancer in years. Degarelix works by inhibiting the body's production and release of testosterone, a male sex hormone that can promote the growth of malignancies on the prostate gland.

Unlike other hormonal suppressants for prostate cancer, degarelix does not cause an initial surge of testosterone and, therefore, won't cause tumors to grow before shrinking them.

Clinical Data Supporting Effectiveness of Degarelix

The FDA's recent approval of degarelix came following the promising results of a nearly two-year long clinical trial, which spanned from February 2006 to October 2007.

During this intensive study, researchers divided the 504 participants into three groups:

• One that received an initial 240mg injection of degarelix and subsequent 80mg maintenance injections once a month for 11 months.
• One that received an initial 240mg injection of degarelix and subsequent 160mg maintenance injections once a month for 11 months.
• One that received monthly 7.5mg injections of leuprolide, a medication that suppresses estrogen production.

Following their analyses, researchers found:

• 96 percent of those who received 240mg/80mg degarelix injections experienced a dramatic drop in testosterone levels (such that levels of testosterone were 1/8 of what they were at the start of the clinical trial).
• 95.5 percent of those who received 240mg/160mg degarelix injections experienced a similar drop in their testosterone levels.

Such drops in testosterone levels mimic those that occur when the testes are removed.

Degarelix Cautions

While degarelix has been proven to effectively treat prostate cancer, this new medication isn't without its side effects, which typically include:

• fatigue
• hot flashes
• injection-site reactions (pain, redness and inflammation)
• weight gain

Despite such degarelix side effects, however, in most cases, the benefits of using this drug outweigh the risks, as prostate cancer is the second leading cause of cancer-related deaths in American men (only behind lung cancer).

(Sources: FDA)

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