Pharmaceutical Business review

FDA approves Abbott prostate cancer formulation

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.