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# Foresee Pharma’s 3-Month Camcevi Formulation OK’d
- URL: https://www.fdaweb.com/foresee-pharmas-3-month-camcevi-formulation-okd/
- Published: 2025-08-29T12:00:00.000Z
- Updated: 2026-09-14T15:20:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159789

FDA has approved a Foresee Pharmaceuticals NDA for Camcevi ETM (leuprolide mesylate), a once every three months injectable formulation for treating advanced prostate cancer. The drug was previously approved for six-month dosing. 

The approval was based on data from a Phase 3 study involving 144 patients with advanced prostate cancer. The trial met its primary endpoint, with 97.9% of participants achieving the required level of testosterone suppression, according to the company. Camcevi ETM is exclusively licensed to Accord BioPharma for commercialization in the U.S.