{"id":26720,"date":"2021-01-26T12:00:00","date_gmt":"2021-01-26T12:00:00","guid":{"rendered":"https:\/\/www.cancer.gov\/news-events\/cancer-currents-blog\/2021\/fda-relugolix-prostate-cancer-androgen-deprivation-therapy"},"modified":"2024-11-03T15:15:48","modified_gmt":"2024-11-03T15:15:48","slug":"relugolix-approval-expected-to-alter-treatment-for-advanced-prostate-cancer","status":"publish","type":"post","link":"https:\/\/ogkologos.com\/en\/relugolix-approval-expected-to-alter-treatment-for-advanced-prostate-cancer\/","title":{"rendered":"Relugolix Approval Expected to Alter Treatment for Advanced Prostate Cancer"},"content":{"rendered":"

\n
\n
\"Image<\/div>
\n
\n

Relugolix binds to receptors for the hormone GnRH on the pituitary gland, decreasing the production of other hormones by the pituitary and, consequently, testosterone by the testes.<\/p>\n

Credit: Courtesy of Dr. Neal Shore<\/p>\n<\/div>\n<\/figcaption><\/figure>\n<\/div>\n

A new drug approved by the Food and Drug Administration (FDA) is expected to immediately affect the treatment of some men with prostate cancer. In a large clinical trial<\/a>, the drug, relugolix (Orgovyx)<\/a>, was shown to be more effective at reducing testosterone<\/a> levels in men with advanced prostate cancer than another commonly used treatment, leuprolide (Lupron)<\/a>.<\/p>\n

Treatments that block the production of the hormone<\/a> testosterone by the testes have been the cornerstone of advanced prostate cancer treatment for several decades. Known as androgen deprivation therapy<\/a> (ADT), these treatments are akin to putting a stopper in a car\u2019s gas tank: robbing prostate tumors of the fuel they need to grow and spread.<\/p>\n

In the clinical trial, relugolix was also much less likely than leuprolide to cause serious heart issues, said Neal Shore, M.D., of the Carolina Urologic Research Center, who led the clinical trial on which the approval was based, called HERO. That\u2019s important, Dr. Shore said, because leuprolide and other ADT drugs have been linked with an increased risk of cardiac events, including heart attacks and heart failure.<\/p>\n

\u201cFor me, this [approval] is significant,\u201d Dr. Shore said. \u201cMany of the patients we start on testosterone suppression are at risk of having a cardiac complication.\u201d<\/p>\n

Given its superior ability to reduce testosterone and safety with regard to heart-related effects, Dr. Shore said, \u201cit\u2019s perfectly arguable\u201d that relugolix should be the preferred choice for ADT in men with advanced prostate cancer.<\/p>\n

Alicia Morgans, M.D., who specializes in treating prostate cancer at the Robert H. Lurie Cancer Center of Northwestern University, generally agreed.<\/p>\n

\u201cI believe this is a new standard of care<\/a> for men with [advanced] prostate cancer,\u201d Dr. Morgans said. \u201cIt meaningfully and effectively lowered testosterone levels, which is what we manipulate to try to control prostate cancer.\u201d<\/p>\n

It may not \u201cnecessarily replace every [ADT] option for every patient, but it\u2019s definitely a new standard that appears safe and effective,\u201d she continued, especially for men concerned about any potential heart-related risks.<\/p>\n

Going After Testosterone<\/h2>\n

Prostate cancer that is confined to the prostate is typically treated with surgery or radiation therapy<\/a>. Once it advances beyond the prostate, either to nearby tissues or to other parts of the body (e.g., bones, liver), ADT is typically used.<\/p>\n

Although several drugs for ADT are available, in the United States leuprolide is the most commonly used option. Known as an LHRH agonist<\/a> (also called a GnRH agonist), leuprolide acts on the pituitary gland<\/a>\u2014a tiny organ within the brain that is responsible for producing a hormone that eventually decreases the production of testosterone by the testicles. It is given to patients as an injection into muscle, typically every few months.<\/p>\n

Reducing the production of testosterone to very low levels with drugs is often called medical (or chemical) castration<\/a>, because it achieves the same results as surgical removal of the testes.<\/p>\n

Relugolix is known as a GnRH (or LHRH) antagonist<\/a>. It also acts on the pituitary gland, but in a way that more directly and rapidly blocks testosterone production in the testes. In addition, it is a pill that patients take every day.<\/p>\n