PDUFA Date Set for 3-Month Variation of Leuprolide Mesylate in Advanced Prostate Cancer

Leuprolide Mesylate in Advanced Prostate

Cancer | Image Credit: © Sebastian Kaulitzki

- stock.adobe.com

The FDA has issued a Day-74 letter stating that the Prescription Drug User Fee Act (PDUFA) goal date for a decision regarding the marketing approval for the 3-month, 21-mg variation of leuprolide mesylate (Camcevi) for the treatment of adult patients with advanced prostate cancer is August 29, 2025.¹

The new drug application for the 3-month version of leuprolide mesylate is supported by findings from a phase 3 trial (NCT03261999).² Previously reported data from the study demonstrated that patients in the intention-to-treat population (n = 144) achieved 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 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).

No mean increase in testosterone was reported following the second injection of leuprolide mesylate. Among patients who did not achieve the primary end point (n = 3), 2 did not achieve castration level on day 28 and 1 had transient testosterone escape after the second injection.

“This marks another important regulatory milestone for the [leuprolide mesylate] franchise,” Ben Chien, PhD, founder, chairman, and CEO, of Foresee Pharmaceuticals, stated in a 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 [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.”

In May 2021, the FDA approved the 6-month subcutaneous depot formulation of leuprolide mesylate for the treatment of patients with advanced prostate cancer.³

The phase 3, global, open-label, single-arm trial enrolled adult patients with carcinoma of the prostate who were candidates for androgen ablation therapy.⁴ Eligible patients also needed to have a baseline morning serum testosterone level of over 150 ng/dL, an ECOG performance status of 2 or less, a life expectancy of at least 18 months, and adequate laboratory values.

All patients received leuprolide mesylate at a dose of 25 mg on day 0 and a second dose on day 84; patients were followed until day 168. The secondary end point was safety and tolerability based on the incidence of adverse effects (AEs).

In the safety population (n = 90), 217 any-grade treatment-emergent AEs (TEAEs) occurred.² Grade 1 TEAEs were reported in 87.8% of patients and grade 2 TRAEs occurred in 31.1%. Severe TEAEs occurred at a rate of 7.78%; most TEAEs were mild or moderate in intensity. The most common AEs that occurred in over 5% of patients included hot flushing (24.31%), hypertension (11.11%), increased body weight (7.64%), and injection site hemorrhage (5.56%).

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 13, 2025. https://www.foreseepharma.com/en/news/category/press_releases/tbc?page=1
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 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
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