FDA

Camcevi ETM OK’d for advanced prostate cancer

September 4, 2025

FDA approved Camcevi ETM, a long-acting formulation of leuprolide mesylate 21 mg administered SC every 3 months, for the treatment of advanced prostate cancer.

Camcevi was previously approved as a 42-mg SC injection administered once every 6 months.

Efficacy

The efficacy of Camcevi ETM was evaluated in an open label, single arm, multinational study (FP01C17-001; NCT03261999) involving 144 patients with advanced prostate carcinoma who had a screening morning serum testosterone level >150 ng/dL and Eastern Cooperative Oncology Group performance status ≤2. Camcevi ETM was administered SC at a dose of 21 mg initially on day 0 and on week 12.

The major efficacy outcome measure was medical castration rate, defined as achieving and maintaining serum testosterone suppression to <50 ng/dL by week 4 through week 24 of treatment. Following the first injection of Camcevi ETM, serum testosterone levels were suppressed to <50 ng/dL by week 4 in 97.9% of the patients; and from week 4 through week 24 in 97.2% of patients estimated using the Kaplan-Meier method. On day 28, the percentage of patients with testosterone suppression to <20 ng/dL was 70.8%.

PSA levels were monitored and were lowered on average by 48% after 4 weeks after administration of Camcevi ETM, 88% after 3 months and remained suppressed throughout the 24 weeks of treatment. These PSA results should be interpreted with caution because of the heterogeneity of the patient population studied. No evidence has shown that the rapidity of PSA decline correlates with clinical benefit.

Safety

The most common (≥5%) adverse reactions reported with Camcevi ETM were increased triglycerides, increased ALT and AST, hot flush, hypertension, decreased hemoglobin, increased sodium, injection site reaction, weight increase, increased potassium, decreased neutrophils, and decreased WBCs.

Sources:

Camcevi ETM (leuprolide) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219745s000lbl.pdf Revised August 2025. Accessed September 3, 2025.

Foresee Pharmaceuticals announces FDA approval of Camcevi ETM for the treatment of advanced prostate cancer. [News release]. 2025. https://www.foreseepharma.com/en/news/category/press_releases/foresee_pharmaceuticals_announces_fda_approval_of_camcevi_etm_for_the_treatment_of_advanced_prostate_cancer