Camcevi® (leuprolide mesylate) 42mg injection is now available for the treatment of advanced prostate cancer in adult patients.
Camcevi is a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, a gonadotropin-releasing hormone agonist. The approval was based on data from an open-label, single-arm phase 3 study (ClinicalTrials.gov Identifier: NCT02234115) that evaluated the efficacy and safety of Camcevi in 137 adults with advanced prostate carcinoma.
Patients received Camcevi administered subcutaneously at a dose of 42mg initially on day 0 and on week 24. The primary endpoint was the percentage of patients with suppression of serum testosterone (50ng/dL or less) by week 4 through week 48 in the intent-to-treat population.
Following the first injection of Camcevi, serum testosterone levels were suppressed to 50 ng/dL or less by week 4 in 98.5% of patients; and from week 4 through week 48 in 97.0% of patients (95% CI, 92.2-98.9). The most common adverse reactions were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.
Camcevi is available in a kit as a single-dose, prefilled syringe containing 42mg of leuprolide for subcutaneous injection; the product must be administered by a health care provider. To help manage in-practice inventory of Camcevi, the Company is offering providers access to AccordConnects, a mobile application.
- Accord BioPharma announces US launch for Camcevi™ (leuprolide) injection emulsion for the treatment of advanced prostate cancer in adults. News release. Accord BioPharma. Accessed March 31, 2022. https://www.prnewswire.com/news-releases/accord-biopharma-announces-us-launch-for-camcevi-leuprolide-injection-emulsion-for-the-treatment-of-advanced-prostate-cancer-in-adults-301515068.html
- Camcevi. Package insert. Accord BioPharma; 2022. Accessed March 31, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211488s000lbl.pdf