The Food and Drug Administration (FDA) has approved Camcevi® (leuprolide mesylate) 42mg injection for the treatment of advanced prostate cancer in adult patients.
Camcevi is a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, a gonadotropin-releasing hormone agonist. The approval was based on data from an open-label, single-arm phase 3 study (ClinicalTrials.gov Identifier: NCT02234115) that evaluated the efficacy and safety of Camcevi in 137 adults with advanced prostate carcinoma.
Patients received Camcevi 42mg administered subcutaneously as 2 injections given 6 months apart. The primary endpoint was the percentage of patients with suppression of serum testosterone (50ng/dL or less) by day 28 and from day 28 to day 336 in the intent-to-treat population.
Results demonstrated a suppression rate of 97%, with mean testosterone concentration suppressed below castrate levels to 17.6ng/dL on day 28. The most common adverse reactions were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.
Camcevi is exclusively licensed to Accord BioPharma in the US for commercialization.
Foresee Pharmaceuticals announces FDA approval of Camcevi® for the treatment of advanced prostate cancer; Accord BioPharma to head the U.S. commercialization. [press release]. Taipei, Taiwan: Foresee Pharmaceuticals; May 26, 2021.