The FDA has approved 21 mg leuprolide mesylate (Camcevi ETM, Foresee Pharmaceuticals) as a ready-to-use long-acting injectable emulsion to be administered every 3 months for the treatment of advanced prostate cancer.

A 42 mg 6-month formulation of Camcevi — a gonadotropin-releasing hormone agonist — was approved for the same indication in 2021. 

Approval of the 21 mg 3-month formulation was based on safety and efficacy demonstrated in FP01C-17-001, a global, multi-national phase 3 clinical study. Of 144 patients with advanced prostate cancer who were enrolled, 97.9% achieved the primary efficacy endpoint of medical castration, which was defined as achieving and maintaining serum testosterone suppression to less than 50 ng/dl by week 4 through week 24 of treatment, Foresee Pharmaceuticals announced in a press release. 

Study participants had a median age of 70 years, screening morning serum testosterone levels of greater than 150 ng/dl, and Eastern Cooperative Oncology Group performance status of 2 or less. The treatment was injected subcutaneously at a dose of 21 mg on day 0 and at week 12. At day 28, 70.8% of patients had testosterone suppression to less than 20 ng/dl, according to the prescribing information.

The earlier approval of the 42 mg 6-month formulation was based on findings from the open-label, single-arm FP01C-13-001 study. In that study, 98.5% of patients had serum testosterone levels suppressed to 50 mg/dl or less by week 4 and in 97.0% from week 4 through week 48. The percentage of patients with testosterone suppression to 20 mg/dl or less was 69.3% at day 28, according to the prescribing information on the FDA website.

Adverse reactions occurring in at least 5% of patients receiving the 21 mg dose were increased triglycerides, increased alanine aminotransferase, hot flush, hypertension, decreased hemoglobin, increased sodium, increased aspartate aminotransferase, injection site reaction, weight increase, increased potassium, decreased neutrophils, and decreased white blood cells.

Like the 42 mg formulation, Camcevi ETM will be marketed exclusively by Accord BioPharma, the US specialty division of Intas Pharmaceuticals, according to the press release.

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@mdedge.com or on X: @SW_MedReporter.