Oral Hormone Therapy for Advanced Prostate Cancer

The FDA approved the first once-a-day pill to lower the levels of testosterone in certain patients with prostate cancer.

oral relugolix approved for certain patients with prostate cancer

The U.S. Food and Drug Administration (FDA) has approved the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix, (Orgovyx), for adult patients with advanced prostate cancer. GnRH antagonists belong to a class of hormone therapy medications designed to lower the amount of testosterone in the body. Testosterone is a male sex hormone that can fuel the growth of prostate cancer cells. 

As opposed to receiving the medication through an injection or an implantable device, relugolix is taken orally once a day, which potentially could result in fewer doctor visits for patients. As a type of androgen deprivation therapy, relugolix is a GnRH antagonist that blocks the GnRH receptor, thus reducing the production of testosterone. 

The data to demonstrate the efficacy of the new delivery method for this oral agent was evaluated in a randomized, open-label trial in men who required at least one year of androgen deprivation therapy due to either prostate cancer recurrence following radiation or surgery or in men with newly diagnosed castration-sensitive advanced prostate cancer.A total of 934 patients were randomly assigned either to a group that received the oral medication or to a control arm that received injections with the current standard of care luteinizing hormone-releasing hormone (LHRH) agonist. The patients receiving relugolix showed a 96.7 percent response rate in achieving and maintaining serum testosterone suppression levels.

Prostate cancer is the most common non-skin cancer diagnosed in men. According to federal statistics, more than 190,000 men in the U.S are diagnosed with prostate cancer every year. 

The FDA rendered its approval on December 18, 2020.