FDA approves new subcutaneous formulation of leuprolide mesylate for prostate cancer

The FDA has approved a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate (Camcevi 42 mg) for the treatment of patients with advanced prostate cancer, according to Foresee Pharmaceuticals, the developer of the treatment.1

The approval was based on findings from a phase 3 trial, in which the primary efficacy end points were the percentage of subjects with suppression of serum testosterone (≤50 ng/dl) by day 28 and from day 28 to day 336.2 These primary end points were successfully achieved, as 97% of subjects had a serum testosterone level ≤50 ng/dL by the end of the trial. Further, 95.9% of patients reached a serum testosterone level ≤20 ng/dL.

"The approval of Camcevi 42 mg is a significant step toward our mission in improving the standard of care and the lives of patients," Dr. Ben Chien, founder and Chairman of Foresee, stated in a press release. "It also demonstrates the success of Foresee's pioneering Stabilized Injectable Formulation (SIF) technology. We want to thank the tireless work from the team and all stakeholders, which has made this approval possible.”

The open-label, multicenter phase 3 study enrolled 137 patients with prostate cancer and an indication for androgen ablation. The patients were treated with 2 subcutaneous injections of leuprolide mesylate subcutaneous injectable suspension at 50 mg. The injections were administered 6 months apart and patients were followed for an additional 6 months.

Overall, 15 (10.9%) patients did not finish the study. Five of these patients discontinued early due to an adverse event (AE).

A castrate testosterone level was achieved by 98.5% of patients by day 28. On day 28, the mean testosterone concentration was suppressed below castrate levels to 17.6 ng/dL. The investigators also noted that following the first injection of leuprolide mesylate subcutaneous injectable suspension at 50 mg, PSA levels were significantly reduced, and this PSA reduction effect continued to occur to the end of the study.

During the study, the investigators did not observe statistically significant changes in urinary symptom assessments or worsening bone pain. The 2 most common AEs across all grades were hot flush (48.9%) and hypertension (14.6%). Other adverse events occurring in ≥10% of patients included injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.

References

1. Foresee Pharmaceuticals Announces FDA Approval of CAMCEVI® for the Treatment of Advanced Prostate Cancer; Accord BioPharma to Head the U.S. Commercialization. Published online May 26, 2020. Accessed May 27, 2020. https://prn.to/3wGnEoO.

2. Shore N, Mincik I, DeGuenther M, et al. A phase 3, open-label, multicenter study of a 6-month pre-mixed depot formulation of leuprolide mesylate in advanced prostate cancer patients. World J Urol. 2020;38(1):111-119. doi: 10.1007/s00345-019-02741-7