FDA Approves Subcutaneous Depot Formulation of Leuprolide Mesylate for Prostate Cancer

The ready-to-use subcutaneous formulation of leuprolide mesylate, Camcevi, was approved for use in patients with prostate cancer by the FDA.

FDA approval has been granted to Camcevi, a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate for the treatment of prostate cancer, according to Foresee Pharmaceuticals, who is responsible for the agent.

Data supporting the approval are from a phase 3 trial with 137 patients who were treated with the 42-mg formulation every 6 months. The results indicated the efficacy and safety of the agent, meeting the primary end point of the proportion of patients with serum testosterone suppression by day 28 and from day 28 through 336 in the intention-to-treat (ITT) population.

“The approval of Camcevi 42 mg is a significant step toward our mission in improving the standard of care and the lives of patients,” Ben Chien, founder and Chairman of Foresee, said 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.”

Serum testosterone suppression was defined as a mean concentration level at or below 50 ng/dL. In total, 97% of patients with advanced prostate cancer achieved the primary end point, with a mean testosterone concentration level below castrate levels to 17.6 ng/dL on day 28.

Important safety information for the agent includes the risk of tumor flare in the first few weeks of treatment that could be accompanied by transient worsening of bone pain, ureteral obstruction, spinal cord compression, or occurrence of additional clinical indicators of prostate cancer.

The most common adverse events reported in at least 10% of patients were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.

Providers should also be aware of hyperglycemia and increased diabetes risk that is reported with gonadotropin-releasing hormone (GnRH) agonists, with close blood glucose monitoring recommended. There is an increased risk of cardiac events such as myocardial infarction, sudden cardiac death, and stroke with GnRH agonists. Patients in whom GnRH agonists contraindicated should not receive Camcevi.

Reference

Foresee Pharmaceuticals Announces FDA Approval of Camcevi for the Treatment of Advanced Prostate Cancer; Accord BioPharma to Head the U.S. Commercialization USA. News release. Foresee Pharmaceuticals. May 27, 2021. Accessed May 27, 2021. https://bit.ly/3upDWkz