The FDA has designated August 29, 2025, as the PDUFA goal date for Foresee Pharmaceuticals' new drug application (NDA) for the 3-month formulation of CAMCEVI (leuprolide mesylate) for the treatment of adult patients with advanced prostate cancer. This regulatory milestone brings the potential for a new treatment option closer to approval, offering a different dosing schedule compared to the currently available 6-month formulation.
The NDA is supported by data from a phase 3 clinical trial (NCT03261999) that enrolled 144 patients with advanced prostate carcinoma. The study evaluated the efficacy, safety, and tolerability of leuprolide mesylate injection administered every 3 months. Results showed that 97.9% of patients achieved the primary efficacy endpoint, defined as suppression of serum testosterone to castrate levels (≤50 ng/dL) by day 28 and maintained through day 168 (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.
Efficacy and Safety Profile
The phase 3 trial demonstrated a consistent suppression of testosterone levels with the 3-month leuprolide mesylate formulation. Notably, no mean increase in testosterone was observed following the second injection. Among the few patients (n=3) who did not achieve the primary endpoint, two did not reach castration levels by day 28, and one experienced a transient testosterone escape after the second injection.
Regarding safety, the most common adverse events (AEs) reported in over 5% of patients included hot flushing (24.31%), hypertension (11.11%), increased body weight (7.64%), and injection site hemorrhage (5.56%). The majority of treatment-emergent AEs (TEAEs) were mild or moderate in intensity. Severe TEAEs occurred in 7.78% of patients.
Current Landscape and Future Implications
Leuprolide mesylate is a luteinizing hormone-releasing hormone (LHRH) agonist used for androgen deprivation therapy in advanced prostate cancer. The existing 6-month formulation of CAMCEVI (42 mg) is already approved in the U.S., Canada, EU, Taiwan, Israel, and the UK. The potential approval of the 3-month formulation (21 mg) would provide physicians and patients with a more flexible treatment schedule.
"This marks another important regulatory milestone for the CAMCEVI franchise," stated Dr. Ben Chien, Founder and Chairman of Foresee Pharmaceuticals. "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."
