FDA Approves 3-Month Leuprolide Mesylate Formulation for Advanced Prostate Cancer

The US FDA has granted approval for a 3-month, ready-to-use, long-acting injectable (LAI) formulation of leuprolide mesylate (Camcevi ETM) for the treatment of adult patients with advanced prostate cancer.¹

The approval represents a new option for clinicians and patients, offering a quarterly dosing schedule in a prefilled syringe that eliminates the need for reconstitution. This advancement aims to streamline the administration process and reduce the potential for handling errors associated with multi-step preparations.

The approval is based on a successful phase 3 clinical trial (NCT03261999) that evaluated the efficacy and safety of the new 21-mg formulation. The open-label, single-arm study enrolled a total of 144 adult patients with advanced prostate cancer.² The trial's primary efficacy end point was the achievement of a serum testosterone concentration suppression to castrate levels (<50 ng/dL) from day 28 through day 168. Results from the study demonstrated that leuprolide mesylate was highly effective, with 97.9% of subjects achieving the primary end point.

"The approval of Camcevi ETM (21 mg) is a significant step toward our mission in improving the standard of care and the lives of patients," said Ben Chien, MD, founder, chairman, and CEO of Foresee Pharmaceuticals, in a press release.¹ "It is also a key step in our efforts to build Foresee as a profitable and growing business. We want to thank the team and all stakeholders for their tireless work, which has made this approval possible.

Advanced prostate cancer is often managed with androgen deprivation therapy (ADT) to reduce testosterone levels, which can fuel tumor growth. As a gonadotropin-releasing hormone (GnRH) agonist, leuprolide mesylate works by initially stimulating and then desensitizing the GnRH receptors in the pituitary gland, leading to a sustained suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion. This, in turn, results in a significant reduction in testicular androgen production. The 3-month formulation expands the treatment options for this patient population, providing an alternative to existing GnRH agonists with different administration schedules.

The safety profile of leuprolide mesylate in the phase 3 trial was consistent with the known effects of GnRH agonists. The majority of treatment-emergent adverse events (TEAEs) were reported as mild to moderate in intensity. The most common AEs included hot flushing, hypertension, and injection site reactions. A total of 217 TEAEs were reported among 90 patients, with 165 classified as grade 1 and 43 as grade 2. No new or unexpected safety concerns were identified in the study population.³ Clinicians should continue to monitor patients receiving GnRH agonists for potential side effects such as hyperglycemia, an increased risk of developing diabetes, and cardiovascular events, as well as for the transient worsening of symptoms known as a tumor flare during the initial weeks of treatment.

REFERENCES:

1. Foresee Pharmaceuticals Announces FDA Approval of CAMCEVI ETM for the Treatment of Advanced Prostate Cancer. News release. Foresee Pharmaceuticals. August 29, 2025. Accessed August 29, 2025. https://tinyurl.com/yzk8ap8z

2. Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer. ClinicalTrials.gov. Updated May 4, 2020. Accessed August 29, 2025. https://clinicaltrials.gov/study/NCT03261999

3. Foresee Pharmaceuticals Announces Successful Topline Results from Phase 3 Registration Study of LMIS 25 mg in Prostate Cancer. News release. Foresee Pharmaceuticals. February 21, 2019. Accessed August 29, 2025. https://tinyurl.com/y6zekw2f