FDA Reviews 3-Month Leuprolide Mesylate for Advanced Prostate Cancer
核心洞察
The FDA is reviewing a new drug application for a 3-month depot formulation of leuprolide mesylate for advanced prostate cancer (搜索).
Phase 3 trial data showed 97.9% of patients achieved serum testosterone suppression with the 3-month leuprolide mesylate formulation.
The treatment demonstrated a manageable safety profile, with common adverse events including hot flushing and hypertension.
The FDA is evaluating a new drug application (NDA) for a ready-to-use, 3-month depot formulation of leuprolide mesylate (Camcevi) for the palliative treatment of patients with advanced prostate cancer (搜索). Foresee Pharmaceuticals (搜索) announced the acceptance of their application, potentially expanding treatment options for this patient population.
The NDA is supported by data from an open-label, single-arm phase 3 trial (NCT03261999). The study demonstrated that 97.9% (95% CI, 93.5%-99.3%) of patients treated with leuprolide mesylate achieved suppression of serum testosterone to no more than 50 ng/dL by day 28 and from days 28 to 168. At day 28, the mean testosterone concentration was 17.8 ng/dL, with a suppression rate of 98.6% in evaluable patients (n = 143). No mean increase in testosterone was observed following the second injection.
Ben Chien, PhD, founder and chairman of Foresee Pharmaceuticals (搜索), stated, "Following the successful launch of [the leuprolide mesylate] 6-month depot formulation in 2022, we are excited to announce the submission of the 3-month version of [leuprolide mesylate] NDA to the US FDA... We look forward to the regulatory approval from the FDA in 2025, and commercial launch in 2026, providing patients with its differentiated ready-to-use profile."
The phase 3 trial enrolled patients at least 18 years of age with histologically confirmed carcinoma of the prostate who were candidates for androgen ablation therapy. Key inclusion criteria included a baseline serum testosterone level of more than 150 ng/dL, an ECOG performance status of 0 to 2, a life expectancy of at least 18 months, and adequate laboratory values. Patients were administered leuprolide mesylate at 25 mg on day 0, followed by a second dose on day 84, and were followed until day 168.
Safety Profile
Regarding safety, 90 patients experienced a total of 217 treatment-emergent adverse effects (TEAEs). The most common adverse events reported in more than 5% of patients included hot flushing (24.31%), hypertension (11.11%), increased body weight (7.64%), and injection site hemorrhage (5.56%).