FDA Approves 6-Month Formulation of Leprolide for Advanced Prostate Cancer

The US Food and Drug Administration (FDA) has approved a 45 mg for 6-month administration formulation of leuprolide acetate for depot suspension (Lupron Depot, Abbott) for palliative treatment of advanced prostate cancer. This dosing option adds to the existing formulations, which are injected every 1 month, 3 months, and 4 months.

 

Approval was based on data from a 48-week, open-label study of 151 patients. Patients received 2 injections in 6-month intervals and were followed for nearly 1 year. Overall, testosterone suppression was sustained throughout the treatment period and onset of suppression was consistent with the other dosing formulations.

 

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Last modified: July 22, 2021