The FDA has approved a 6-month subcutaneous depot formulation of leuprolide mesylate as a ready-to-use treatment for patients with advanced prostate cancer.
The FDA has approved a 6-month subcutaneous depot formulation of leuprolide mesylate (Camcevi) as a ready-to-use treatment for patients with advanced prostate cancer.1
The regulatory decision is based on data from a phase 3 study that was conducted in a total of 137 patients with advanced prostate cancer who received the formulation via a 42-mg injection, every 6 months. The primary end point of the trial was suppression of serum testosterone (≤50 ng/dL) by day 28, and from day 28 to day 336 in the intent-to-treat population. Results indicated that 97% of study participants achieved this end point, with mean testosterone concentration was suppressed below castrate levels to 17.6 ng/dL by day 28.
“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 Pharmaceuticals, stated in a press release. “It also demonstrates the success of Foresee’s pioneering Stabilized Injectable Formulation technology. We want to thank the tireless work from the team and all stakeholders, which has made this approval possible.”
In the open-label, multicenter phase 3 trial, investigators set out to determine the safety, efficacy, and pharmacokinetic profile of the agent at 50 mg for up to 1 year of treatment of treatment in patients with advanced prostate cancer.2
Patients who had an indication for androgen ablation therapy were given 2 subcutaneous injections of the product at 50 mg, 6 months apart and were followed for an additional 6 months. Of the 137 patients enrolled, 10.9% (n = 15) did not complete the study, including 5 patients who stopped early due to toxicity. By day 28, 98.5% of patients achieved a castrate testosterone level. By the end of the study, 95.9% of the study participants had serum testosterone level of ≤20 nd/dL.
The agent also resulted in a significant reduction in prostate-specific antigen (PSA) levels following the first injection. Notably, the declination in PSA persisted until the end of the study. Additionally, no significant change in worsening bone pain or urinary symptom assessments was observed.
The agent was found to be well tolerated. Just under half of patients, or 48.9%, experienced hot flush with the product, while 14.6% had hypertension.
“Camcevi 42 mg is an important addition to the rapidly expanding Accord Biopharma oncology portfolio and provides clinicians an important option for the treatment of advanced prostate cancer,” Chrys Kokino, US president of Accord BioPharma specialty products, added in the release.