FDA OKs Leuprolide Mesylate 3-Month Formulation in Advanced Prostate Cancer

Results from a phase 3 trial led to the approval of leuprolide mesylate as a 3-month formulation for patients with advanced prostate cancer.

The FDA has approved leuprolide mesylate (Camcevi) 3-month acting injectable formulation for patients with advanced prostate cancer, according to a press release from the FDA.¹

Results from the approval are based on results from the phase 3 FP-001 LMIS trial (NCT03261999), which assessed the 3-month formulation of the treatment in 144 patients with advanced prostate cancer.^2,3

"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," stated Dr Ben Chien, PhD, the founder, chairman, and chief executive officer of Foresee, in the 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.

In the trial, patients were required to receive at least 1 dose of the study drug, and 132 patients were given 2 doses.

Previously reported results found that the treatment met the primary end point of the trial, with 97.9% of patients achieving a serum testosterone concentration suppression to castrate levels from day 28 through day 168. By day 28, the mean testosterone concentration was suppressed below the castrate levels to 17.8 ng/dL, and the suppression rate was 98.6%.

At the time of the second injection, there was no increase in testosterone observed.

Overall, 3 patients did not have successful suppression of testosterone by the time of the primary efficacy end point analysis. Of the 3, 2 did not achieve castration level by day 28, and 1 patient had transient testosterone escape.

Regarding safety, 217 treatment-emergent adverse effects (TEAEs) from 90 patients were observed. Additionally, 165 events in 79 patients were grade 1, 43 events in 28 patients were grade 2, and 9 TEAEs in 7 patients were classified as severe.

Of note, 24.31% of patients reported hot flushing as the most common AE, followed by hypertension in 11.11%, increased body weight in 7.64%, and injection site hemorrhage in 5.56%.

Patients were included in the trial if they had histologically confirmed carcinoma of the prostate, determined to be a candidate for androgen ablation therapy, have baseline serum testosterone levels of more than 150 ng/dL, and ECOG performance score of 2, and life expectancy of at least 18 months.⁴

Patients were excluded if they had received chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti-androgen therapy concomitantly, or within 8 weeks of the screening treatment for carcinoma of the prostate. Patients were also excluded if they received any vaccine within 4 weeks of the screening visit, history of blood donation within 2 months of the screening visit, history of anaphylaxis to any LH-RH analogues, or had undergone major surgery within 4 weeks of the screening visit.

In May 2021, the FDA approved the 6-month formulation of leuprolide mesylate.⁵

References

1. Foresee Pharmaceuticals announces FDA approval of CAMCEVI ETM for the treatment of advanced prostate cancer. News release. Foresee Pharmaceuticals. August 28, 2025. Accessed August 29, 2025. https://tinyurl.com/mrtx3xsn
2. Foresee Pharmaceuticals announces the PDUFA goal date for the 3-month version of CAMCEVI is August 29, 2025. News release. Foresee Pharmaceuticals. January 13, 2025. Accessed July 10, 2025. https://tinyurl.com/4fbd82d5
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 July 10, 2025. https://tinyurl.com/6x3yy2pv
4. Safety, efficacy, and pharmacokinetic behavior of leuprolide mesylate (LMIS 25 mg) in subjects with prostate cancer. ClinicalTrials.gov. Accessed July 10, 2025. https://tinyurl.com/3pfhc4zu
5. 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 July 10, 2025. https://bit.ly/3upDWkz