CHMP recommends EU approval of 3-month formulation of leuprolide mesylate

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending an expanded approval of leuprolide mesylate (Camcevi) to include a new 3-month formulation (21 mg) of the long-acting injectable (LAI) for adult patients with advanced prostate cancer.¹

The CHMP recommendation will now be reviewed by the European Commission, who is expected to have a final decision on the application in the second quarter of 2026. According to Foresee Pharmaceuticals, the 21 mg option complements the existing 42 mg formulation “by providing more options for stakeholders, streamlining the administration process for clinical staff, and also enhancing patient comfort and treatment compliance.”¹

The 6-month formulation of leuprolide mesylate (42 mg) was previously launched in Europe in 2025. The 21 mg formulation of the agent has been approved by the FDA as of August 2025.

Data on 3-month leuprolide mesylate

The application 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) by day 28 and from day 28 through day 168.²

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

Patients were enrolled in the study throughout 21 clinical trial sites across the US, Europe, and Asia.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.³

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 greater than 90%. The study’s secondary end points were safety and tolerability.

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

The primary efficacy end point was achieved in 97.9% of patients (95% CI, 93.5% to 99.3%). 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.

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.”²

REFERENCES

1. Foresee Pharmaceuticals Welcomes Positive CHMP Opinion Recommending Approval of CAMCEVI 21mg, 3-month strength in the European Union for Advanced Prostate Cancer. News release. Foresee Pharmaceuticals Co, Ltd. March 6, 2026. Accessed March 23, 2026. https://www.prnewswire.com/news-releases/foresee-pharmaceuticals-welcomes-positive-chmp-opinion-recommending-approval-of-camcevi-21mg-3-month-strength-in-the-european-union-for-advanced-prostate-cancer-302706567.html

2. 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

3. 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