The FDA has received a new drug application (NDA) for a 3-month formulation of leuprolide mesylate (Camcevi) for the palliative treatment of advanced prostate cancer. This ready-to-use depot formulation offers a new treatment option for patients. The NDA submission is based on positive results from a phase 3 trial which showed that 97.9% of patients treated with leuprolide mesylate achieved testosterone suppression to below 50 ng/dL. This suppression was maintained from day 28 to day 168 of the study. The FDA previously approved a 6-month formulation of leuprolide mesylate in 2021. Foresee Pharmaceuticals, the company behind the drug, anticipates the 3-month formulation to be approved in 2025 and launched in 2026.

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