FDA Approves Lupron Depot Injections for Palliative Treatment of Prostate Cancer

Jun 22 2011 - 10:57am
Journal of Cell Biology

For men with prostate cancer, when the disease has spread beyond the prostate, hormonal therapy involving the reduction of testosterone is used to slow or prevent further growth of tumors. The FDA has just recently approved a new regimen of a common injection known as Lupron Depot for six-month administration that will give patients an additional treatment option.

Hormonal Therapy Prescribed for Men with Advanced Prostate Cancer

Lupron Depot (leuprolide acetate for depot suspension) is manufactured and marketed by Abbott, a global, broad-based health care company based in Illinois. The injection belongs to a class of mediations known as gonadotropin-releasing hormone (GnRH) agonists which work by suppressing the production of testosterone, a male hormone that is involved in the growth of prostate cancer.

Lupron Depot is approved as a long-acting suspension that is injected intramuscularly once a month, or once every three or four months, for the treatment of symptoms (palliative therapy) for advanced prostate cancer. The benefits of GnRH agonist medications in earlier stages of non-metastatic prostate cancer have not been established.

The newly approved 45 milligram dose allows for a more flexible option of once every six months.

Read: FDA Approves Degarelix for Advanced Prostate Cancer Treatment

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The US Food and Drug Administration (FDA) approved the new formulation of Lupron Depot based on data from a 48-week, open-label study involving 151 patients with prostate cancer. The patients received a total of two injections, 24 weeks apart, and were followed for nearly one year to evaluate testosterone suppression and safety. Overall, testosterone suppression was sustained throughout the treatment period and was consistent with the other currently available Lupron Depot formulations.

The most common side effects were flushing, injection site pain, general pain, respiratory infection, and fatigue. Lupron Depot may also cause impotence and high blood sugar.

Read: Men On Hormone Therapy for Prostate Cancer May Have Greater Cardiovascular Risks

The 45 milligram six-month administration formulation is expected to be available in late June. Full prescribing information for all Lupron Depot formulations can be found at www.rxabbott.com.

More than 200,000 new cases of prostate cancer will be diagnosed this year in the United States. It is the most common type of cancer diagnosed in American men, with one in six being diagnosed at some point in their lifetime.

Image Credit: The Journal of Cell Biology

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