FDA Approved Camcevi ETM New Drug Application for Prostate Cancer

The U.S. Food and Drug Administration (FDA) has approved the New Drug Application, or NDA, for Camcevi ETM (leuprolide mesylate 21 milligrams), a ready-to-use long-acting injectable (LAI) formulation administered every three months, for the treatment of advanced prostate cancer.

The approval was announced in a news release from Forsee Pharmaceuticals Co. Ltd., the biopharmaceutical company behind Camcevi.

As explained by the National Cancer Institute on its website, Camcevi initially causes a patient’s pituitary gland to produce more more luteinizing hormone (LH) and follicle-stimulating hormone (FSH), which temporarily increases testosterone levels in men. Over time, Camcevi lowers the amount of LH and FSH released by the pituitary gland, which leads to a drop in testosterone levels. The treatment may stop the growth of cancer cells that need testosterone to grow.

"The approval of Camcevi ETM (21 mg) is a significant step toward our mission in improving the standard of care and the lives of patients," said Dr. Ben Chien, founder, chairman and CEO of Foresee, in the company’s news release.

The approval, according to the news release, was based on a phase 3 clinical study of 144 patients with advanced prostate cancer. In the study, which was completed in February 2019 according to its listing on clinicaltrials.gov, the primary efficacy endpoint, or the percentage of patients with suppression of serum testosterone by day 28 and from day 28 to day 168 in the intent-to-treat population, was achieved in 97.9% of patients, Forsee announced in 2019.

The company noted at the time that the most common side effects reported in more than 5% of participants in the study included hot flushing, which was experienced by 24.31% of patients, followed by hypertension in 11.11% of patients, increased body weight in 7.64% of patients and injection site hemorrhage in 5.56% of patients, with most treatment-related side effects being mild or moderate in intensity.

According to the drug’s prescribing information, serious side effects occurred in 6% of patients who received treatment with Camcevi ETM, with serious adverse reactions including acute myocardial infarction, or a heart attack, as well as cerebrovascular accident, also known as a stroke, drug-induced liver injury and pancreatitis, each experienced by 0.7% of patients. Additionally, permanent discontinuation of the drug due to a side effect occurred due to a stroke in 0.7% of patients.

Furthermore, the most common side effects, including laboratory abnormalities, reported in the prescribing information, included 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.

Prior to this most recent FDA approval, a 42 milligrams injection emulsion iteration of Camcevi for subcutaneous use was approved by the FDA in May 2021 for the treatment of adult patients with advanced prostate cancer.

Prostate Cancer Statistics

In 2025 in the United States, there will be approximately 313,780 new cases of prostate cancer and about 35,770 deaths from the disease, according to a report from the American Cancer Society, which noted that since 2014 the incidence rate of prostate cancer has increased by 3% per year.

The American Cancer Society notes that approximately one in eight men will receive a diagnosis of prostate cancer during their lifetime, with about six in 10 cases developing in men who are 65 years old or older.

Prostate cancer, the American Cancer Society noted, is the second-leading cause of cancer death in American men, second only to lung cancer, and approximately one in every 44 men will die of prostate cancer.

References

1. “Foresee Pharmaceuticals Announces FDA Approval of CAMCEVI ETM for the Treatment of Advanced Prostate Cancer,” news release, Aug. 28, 2025.
2. “Camcevi,” National Cancer Institute; https://www.cancer.gov/publications/dictionaries/cancer-terms/def/camcevi
3. “Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer;” https://clinicaltrials.gov/study/NCT03261999
4. “HIGHLIGHTS OF PRESCRIBING INFORMATION;” https://www.accordbiopharma.com/our-therapies/camcevi/camcevi_pi.pdf
5. “Foresee Pharmaceuticals Announces Successful Topline Results from Phase 3 Registration Study of LMIS 25 mg in Prostate Cancer,” news release, Feb. 21, 2019.
6. “CAMCEVI® (leuprolide) 42mg injection emulsion, FDA Approved for Treatment of Advanced Prostate Cancer, Available Exclusively at Biologics by McKesson,” news release, June 19, 2024.

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