Approved: New Prostate Cancer Rx

FDA approves Orgovyx (relugolix) to treat adults with advanced prostate cancer

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new oral hormone therapy for advanced prostate cancer.

The FDA approved Orgovyx (relugolix) to treat adults who have advanced prostate cancer.

“Today’s approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider,” said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases, in a press release. “This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic.”

Advanced prostate cancer is often treated with androgen deprivation therapy. Often injected under the skin or placed under the skin as a small implant, this treatment reduces levels of certain hormones that help prostate cancer cells grow. Orgovyx works in a similar way, but it is an oral medication, which means it can be more easily administered than many other treatment options.

This new treatment was studied in a trial that included men with advanced prostate cancer. The participants received either Orgovyx or another medication that targets and reduces testosterone. Nearly 97 percent of participants receiving Orgovyx saw low enough levels of testosterone to help reduce cancer growth, according to the FDA.

Common side effects of Orgovyx included increased glucose, hot flush, musculoskeletal pain, increased triglycerides, constipation, decreased hemoglobin, fatigue, increased levels of certain liver enzymes and diarrhea. According to the FDA, this medication and other androgen therapies can affect electrolytes and electrical properties of the heart, as well as cause pregnancy loss.

The FDA approved Orgovyx for Myovant Sciences.

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Review Date: 
December 23, 2020