FDA approves 3-month formulation of leuprolide mesylate for advanced prostate cancer

The FDA has granted approval to a 3-month formulation of leuprolide mesylate (Camcevi ETM; 21 mg) long-acting injectable (LAI) for adult patients with advanced prostate cancer, Foresee Pharmaceuticals announced in a news release.¹

A 6-month formulation of leuprolide (50 mg) was previously approved by the FDA in May 2021,² followed by a US market launch of the drug in April 2022. The 6-month formulation is also currently approved for advanced prostate cancer in the EU, Canada, Taiwan, Israel, and the UK.

"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 Dr. Ben Chien, founder, chairman, and CEO of Foresee, in a news release from the company.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."

Foresee plans a commercial launch of leuprolide mesylate 21 mg after receiving a J-code.

Data on 3-month leuprolide mesylate

The approval is supported by findings from an open-label, single-arm, phase 3 trial (NCT03261999) of leuprolide mesylate administered as 2 injections, 3 months apart in patients with advanced prostate cancer. Overall, the study met its primary end point with 97.9% of patients achieving a serum testosterone concentration suppression to castrate levels (≤ 50 ng/dL) from day 28 through day 168.³

In total, the study enrolled 144 adult patients with advanced prostate cancer who received at least 1 dose of 25 mg leuprolide injection. Of these, 132 patients received a second dose of the drug 12 weeks following the first injection.

At the 28-day timepoint, the suppression rate was 98.6% (141/143) among patients in the intent-to-treat population. The mean testosterone concentration was suppressed to 17.8 ng/dL, below castrate levels. There was no reported mean increase in testosterone following the second injection.

Regarding safety, leuprolide mesylate was well-tolerated in the trial, with the majority of treatment-emergent adverse events (TEAEs) being mild to moderate in intensity. In total, there were 217 (TEAEs) reported among 90 patients. Of those, 165 TEAEs were grade 1 and 43 TEAEs were grade 2. Severe TEAEs were reported in 7 patients.

The most common adverse events in the study were hot flushing (24.31%), hypertension (11.11%), increased body weight (7.64%), and injection site hemorrhage (5.56%).

According to Foresee Pharmaceuticals, “These data are similar to those of LMIS 50 mg (6-month formulation) and other marketed LH-RH agonists in the same patient population.”

Patients were enrolled in the study throughout 21 clinical trial sites across the United States, Europe, and Asia.⁴

Participants were eligible for enrollment if they had a baseline morning serum testosterone level greater than 150 ng/dL at the time of screening, an ECOG performance score of 2 or below, and a life expectancy of at least 18 months. Patients also needed to be candidates for androgen ablation therapy, per the judgment of the attending physician or principal investigator.

The primary end point for the study was the percentage of patients who achieved suppression of serum testosterone to castrate levels (≤ 50 ng/dL) at day 28 and from day 28 through day 168, with a goal of the lower limit of the 2-sided 95% confidence interval being below 90%. The study’s secondary end points were safety and tolerability.

Patients in the study were followed for up to 168 days.

REFERENCES

1. Foresee Pharmaceuticals Announces FDA Approval of CAMCEVI ETM for the Treatment of Advanced Prostate Cancer. Foresee Pharmaceuticals. 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 FDA approval of CAMCEVI for the treatment of advanced prostate cancer; Accord BioPharma to head the U.S. commercialization. News release. Foresee Pharmaceuticals. May 26, 2021. Accessed August 28, 2025. https://www.foreseepharma.com/en-us/news/1/340

3. Foresee Pharmaceuticals announces successful topline results from phase 3 registration study of LMIS 25 mg in prostate cancer. News release. Foresee Pharmaceuticals Co, Ltd. February 21, 2019. Accessed August 28, 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

4. Safety, efficacy, and pharmacokinetic behavior of leuprolide mesylate (LMIS 25 mg) in subjects with prostate cancer. ClinicalTrials.gov. Last updated May 4, 2020. Accessed August 28, 2025. https://clinicaltrials.gov/study/NCT03261999