FDA accepts NDA for 3-month leuprolide mesylate formulation for advanced prostate cancer

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

The NDA is supported by findings from a phase 3 trial.

The Prescription Drug User Fee Act (PDUFA) target action date has been set for August 29, 2025.

A 6-month formulation of leuprolide 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, and Israel.

"This marks another important regulatory milestone for the CAMCEVI franchise," said Ben Chien, PhD, founder and chairman of Foresee, in the news release.¹ "With the PDUFA goal date now set, we look forward to working with the FDA through the regulatory process to bring this treatment option closer to potential regulatory approval, followed by the successful commercial launch of CAMCEVI 21 mg in near future, providing patients and the medical community with a 3-month CAMCEVI LAI in addition to CAMCEVI 42 mg 6-month LAI, currently on the market. Foresee will have a complete, differentiated ready-to-use franchise."

Data on 3-month leuprolide mesylate

The NDA 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

At the day 28 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, there were 217 treatment-emergent adverse events (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.”

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.

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 the PDUFA goal date for the 3-month version of CAMCEVI is August 29, 2025. News release. Foresee Pharmaceuticals, Co, Ltd. Published online and accessed January 13, 2025. https://www.foreseepharma.com/en/news/category/press_releases/tbc?page=1

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 January 13, 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 January 13, 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 January 13, 2025. https://clinicaltrials.gov/study/NCT03261999