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FDA approves Abbott prostate cancer formulation

The US Food and Drug Administration (FDA) has approved Abbott’s new 45 mg six-month formulation of Lupron Depot (leuprolide acetate for depot suspension) for the palliative treatment of advanced prostate cancer.

Lupron Depot, which belongs to a class of medications known as gonadotropin releasing hormone (GnRH) agonists, suppresses the production of the hormone testosterone.

This testosterone suppression can help slow or stop the growth of hormone-dependent cancer cells, and may reduce pain and other symptoms related to advanced prostate cancer.

The FDA’s approval was backed by new data from a 48-week, open-label study, in which 151 prostate cancer patients who received a total of two injections, 24 weeks apart, were followed for nearly 12 months to evaluate testosterone suppression and safety.

Overall, testosterone suppression with this new 45 mg six-month depot formulation was sustained in patients throughout the treatment period.