FDA Approves Camcevi ETM, a 3-Month Formulation of Leuprolide Mesylate for Advanced Prostate Cancer

The FDA approved leuprolide mesylate 21 mg, a long-acting injectable formulation administered every three months (Camcevi ETM, Foresee Pharmaceuticals), as a treatment for advanced prostate cancer.

The FDA approval was based on a phase 3 clinical study with a total of 144 advanced prostate cancer patients enrolled, in which treatment with Camcevi ETM was demonstrated to be effective, safe and well tolerated, with 97.9% of the participants achieving the primary efficacy end point. The primary end