Prostate cancer is one of the most common cancers in the United States. Dr. Richard Pazdur, Director of the Office of Oncology Products at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, stated: “Prostate cancer is the second leading cause of cancer-related deaths among U.S. men, and these patients need more treatment options.”

Currently, treatment for prostate cancer can be tailored to the disease stage and may include radical prostatectomy, radiation therapy, chemotherapy, and hormone therapy.

This newly approved drug is a gonadotropin-releasing hormone (GnRH) receptor antagonist, primarily indicated for patients with advanced prostate cancer. It works by suppressing testosterone levels to slow the progression of the disease.

Historically, hormone therapy for prostate cancer has been characterized by a “rise-and-fall” pattern: at the outset of treatment, certain regimens cause a sharp surge in testosterone levels before their therapeutic effect—namely, the reduction of testosterone—becomes apparent. This means that, in the early phase of treatment, the tumor may not only fail to be suppressed but could even be stimulated to grow. In contrast, Degarelix delivers clinical efficacy from the very beginning; a head-to-head clinical trial comparing it with leuprolide, the hormone drug currently used to treat advanced prostate cancer, demonstrated that Degarelix does not induce the common “rise-and-fall” phenomenon in testosterone levels.

The FDA also stated that, in patients taking these two drugs, testosterone levels achieved through cancer treatment can be comparable to those attained with prostatectomy.

In clinical studies, the most commonly observed adverse events with degarelix, in addition to injection-site reactions (pain, erythema, and swelling), include hot flashes, weight gain, fatigue, and elevations in certain liver enzyme levels. (Dong Jiangping)