FDA Approves 3-Month Version of Leuprolide Mesylate for Advanced Prostate Cancer

The FDA has approved a 3-month, 21-mg subcutaneous depot formulation of leuprolide mesylate (Camcevi ETM) for the palliative treatment of adult patients with advanced prostate cancer.1

The regulatory decision was supported by data from a global, open-label, single-arm phase 3 study (NCT03261999), which demonstrated that leuprolide mesylate produced sustained suppression of serum testosterone to castration levels in the majority of treated patients. In the intention-to-treat population (n = 144), 97.9% (95% CI, 93.5%-99.3%) of patients achieved the primary end point, with a suppressed serum testosterone level of no more than 50 ng/dL by day 28 and from days 28 to 168.2

Among evaluable patients (n = 143), 98.6% achieved castration by day 28, with a mean testosterone concentration of 17.8 ng/dL at that time point. No mean increase in testosterone was observed after the second injection. Three patients did not achieve the primary end point: two failed to reach castration by day 28, and one experienced transient testosterone escape after the second injection.

Previously in 2021, the FDA approved a 6-month, 42-mg formulation of leuprolide mesylate for the treatment of adult patients with advanced prostate cancer.3

"The approval of [leuprolide mesylate] (21 mg) is a significant step toward our mission in improving the standard of care and the lives of patients," Dr. Ben Chien, PhD, founder, chairman, and chief executive officer of Foresee Pharmaceuticals, stated in a news release. "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."

Study Breakdown

The phase 3 trial enrolled adult patients with histologically confirmed carcinoma of the prostate who were candidates for androgen ablation therapy.4 Eligible patients had baseline morning serum testosterone levels greater than 150 ng/dL, an ECOG performance status of 2 or less, a life expectancy of at least 18 months, and adequate laboratory parameters.

Key exclusion criteria included receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti-androgen therapy within 8 weeks before screening, except radiation for pain control; recent vaccination within 4 weeks; blood donation within 2 months; or a history of anaphylaxis to LHRH analogues. Use of LHRH suppressive therapy within 6 months, major surgery within 4 weeks, and clinical or radiographic evidence of central nervous system/spinal cord metastases or risk for spinal cord compression were exclusionary, as were active urinary tract obstruction, prior bilateral orchiectomy, adrenalectomy, hypophysectomy, hypogonadism, or recent testosterone supplementation.

All patients received leuprolide mesylate subcutaneously at a dose of 25 mg on day 0 and again on day 84, with follow-up through day 168.

The primary end point was suppression of serum testosterone to no more than 50 ng/dL by day 28, with this level maintained from days 28 through 168.

Safety Profile

The study’s secondary end point was safety and tolerability, evaluated in the safety population (n = 90).2 A total of 217 treatment-emergent adverse effects (TEAEs) were reported. Grade 1 TEAEs occurred in 87.8% of patients, grade 2 TEAEs in 31.1%, and grade 3 or higher TEAEs in 7.78%. The most common AEs occurring in more than 5% of patients included hot flushing (24.31%), hypertension (11.11%), increased body weight (7.64%), and injection site hemorrhage (5.56%). Most toxicities were mild to moderate in severity, and no unexpected safety signals emerged.

References

1. Foresee Pharmaceuticals announces FDA approval of Camveci ETM for the treatment of advanced prostate cancer. News release. Foresee Pharmaceuticals, Co., Ltd. August 28, 2025. Accessed August 29, 2025. https://www.prnewswire.com/news-releases/foresee-pharmaceuticals-announces-fda-approval-of-camcevi-etm-for-the-treatment-of-advanced-prostate-cancer-302541714.html
2. 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 18, 2025. https://www.prnewswire.com/news-releases/foresee-pharmaceuticals-announces-successful-topline-results-from-phase-3-registration-study-of-lmis-25-mg-in-prostate-cancer-300799580.html
3. Camcevi. Prescribing information. Updated February 2025. Accessed August 18, 2025. https://www.accordbiopharma.com/our-therapies/camcevi/camcevi_pi.pdf
4. Safety, efficacy, and pharmacokinetic behavior of leuprolide mesylate (LMIS 25 mg) in subjects with prostate cancer. ClinialTrials.gov. Updated May 4, 2020. Accessed August 18, 2025. https://clinicaltrials.gov/study/NCT03261999