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.


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Camcevi is exclusively licensed to Accord BioPharma in the US for commercialization.

Reference

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.