FDA to Review 3-Month Leuprolide Mesylate for Prostate Cancer Treatment

• The FDA issued a Day-74 letter setting August 29, 2025, as the Prescription Drug User Fee Act (PDUFA)date for the 3-month leuprolide mesylate (Camcevi) formulation for advanced prostate cancer.
• Phase 3 trial data (NCT03261999) showed 97.9% of patients achieved testosterone suppression ≤50 ng/dL by day 28 and maintained suppression through day 168, with a mean testosterone level of 17.8 ng/dL at day 28.
• No mean testosterone increase occurred after the second injection; 2 patients did not achieve castration levels by day 28, and 1 experienced transient testosterone escape post-second injection.

A Day-74 letter has been issued by the FDA, confirming that the PDUFA target date for the marketing approval decision on the 3-month formulation of leuprolide mesylate given as a 21-mg variation for the treatment of adult patients with advanced prostate cancer is set for August 29, 2025.¹

Data from a phase 3 trial support the new drug application for the 3-month version of leuprolide mesylate.² Here, the primary end point of suppression of serum testosterone of no more than 50 ng/dL by day 28 and from days 28 to 168 was met in the intention-to-treat population (ITT; n = 144) at a rate of 97.9% (95% CI, 93.5%-99.3%). At day 28, the mean testosterone concentration was 17.8 ng/dL, with a suppression rate of 98.6% among evaluable patients (n = 143).

There was no mean increase in testosterone observed after the second injection of leuprolide mesylate. Of the 3 patients who did not meet the primary end point, 2 failed to achieve castration levels by day 28, and 1 had transient testosterone escape following the second injection.

“This marks another important regulatory milestone for the [leuprolide mesylate] franchise. 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 [leuprolide mesylate] 21 mg in near future, providing patients and the medical community with a 3-month [leuprolide mesylate] long-acting injectable in addition to [leuprolide mesylate] 42 mg 6-month long-acting injectable, currently on the market. Foresee will have a complete, differentiated ready-to-use franchise,” said Ben Chien, PhD, founder, chairman, and chief executive officer of Foresee Pharmaceuticals, in a press release.

Prostate cancer, bladder cancer, men's health care: © Tom - stock.adobe.com

In May 2021, the FDA approved the 6-month subcutaneous depot formulation of leuprolide mesylate for the treatment of advanced prostate cancer.³ The approval was based on a phase 3, global, open-label, single-arm trial that enrolled adults with prostate cancer eligible for androgen ablation therapy.⁴ Eligible patients had a baseline serum testosterone of over 150 ng/dL, an ECOG performance status of 0, 1, or 2, a life expectancy 18 months or more, and adequate lab values.

Patients were given leuprolide mesylate 25 mg on day 0 and day 84, with follow-up until day 168.

In addition to the primary end point of the percentage of patients with suppression of serum testosterone by day 28 and from day 28 to day 168 in the ITT population, safety and tolerability based on the incidence of adverse events (AEs) served as secondary end points of the study.

During the study period, 217 any-grade treatment-emergent AEs (TEAEs) were observed in the safety population (n = 90).² Grade 1 TEAEs were seen in 87.8% of patients and grade 2 TRAEs were seen in 31.1% of patients. Nine TEAEs from 7 patients (7.78%) were classified as severe in severity. Otherwise, the majority of TEAEs were mild or moderate in intensity.

Further, the most commonly observed AEs seen in over 5% of patients included hot flushing (24.31%), hypertension (11.11%), increased body weight (7.64%), and injection site hemorrhage (5.56%). Overall, the treatment was deemed safe and well tolerated.

REFERENCES

1. 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 January 15, 2025. https://tinyurl.com/yfjfmv9k

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 January 15, 2025. https://tinyurl.com/mr3xwtam

3. Foresee Pharmaceuticals announces FDA approval of CAMCEVI for the treatment of advanced prostate cancer; Accord BioPharma to head the US commercialization. News release. Foresee Pharmaceuticals. May 26, 2021. Accessed January 13, 2025. https://prn.to/2RKxNCq

4. Safety, efficacy, and pharmacokinetic behavior of leuprolide mesylate (LMIS 25 mg) in subjects with prostate cancer. ClinicalTrials.gov. Updated May 4, 2020. Accessed January 13, 2025. https://clinicaltrials.gov/study/NCT03261999