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FDA approves 3-month leuprolide mesylate in advanced prostate cancer

On August 29 2025, the U.S Food and Drug Administration (FDA) approved a three-month depot formulation of leuprolide mesylate, a gonadotropin-releasing hormone (GnRH) agonist, in patients with prostate cancer.1

The approval is based on data from a open-label, single-arm, Phase III trial (NCT03261999). 144 patients were enrolled to receive two 25 mg doses of leuprolide mesylate administered subcutaneously on days 0 and 84. The primary endpoint of efficacy, measured by suppression of serum testosterone to castrate levels (≤ 50 ng/dL) from day 28 to day 168, was achieved in 97.9% (95% CI, 93.5-99.3) of patients.2

Safety outcomes were comparable to existing luteinizing hormone-releasing hormone (LH-RH) agonist profiles. In the safety cohort of 90 patients, 217 treatment-emergent adverse events (TEAEs) were recorded. Most were mild (grade 1) or moderate (grade 2), with only a small fraction of severe events. The most frequent adverse events included hot flushes, hypertension, weight increase, and injection-site hemorrhage, which all were reported in more than 5% of patients.2

The three-month ready-to-use formulation will enhance the therapeutic armamentarium for advanced prostate cancer, providing a more flexible dosing interval and potentially enhancing convenience without compromising efficacy or tolerability. Overall, the approval marks a critical next step in extending established long-acting androgen-deprivation therapy beyond the six-month depot already in clinical use.

References:

  1. 逸達生物科技股份有限公司. Foreseepharma.com. 2025 [cited 2025 Aug 29]. Available from: https://www.foreseepharma.com/tw/news/category/%E6%96%B0%E8%81%9E%E7%99%BC%E4%BD%88/%E9%80%B8%E9%81%94%E5%89%8D%E5%88%97%E8%85%BA%E7%99%8C%E6%96%B0%E5%8A%91%E5%9E%8B%E6%96%B0%E8%97%A5_camcevi_%E4%B8%89%E5%80%8B%E6%9C%88%E5%8A%91%E5%9E%8B%E5%8F%96%E5%BE%97%E7%BE%8E%E5%9C%8B%E8%97%A5%E8%AD%89?page=1
  2. ‌Clinicaltrials.gov. 2025 [cited 2025 Aug 29]. Available from: https://clinicaltrials.gov/study/NCT03261999