Orgovyx to Treat Advanced Prostate Cancer in Adults Receives FDA Approval

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Orgovyx is the first oral drug to treat patients with advanced prostate cancer, who were previously treated with intravenous drugs that required clinic visits.

The first oral hormone therapy to treat advanced prostate cancer, Orgovyx (relugolix), has been approved by the Food and Drug Administration (FDA).

“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 Oncology Center for Excellence and acting director of the Office of Oncologic Diseases at the FDA, said in a release from the Agency. “This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic.”

One option currently available to treat patients with advanced prostate cancer is androgen deprivation therapy with drugs to lower hormone levels that aid in cancer cell growth. These drugs are either placed as small implants under the skin or injected. In contrast, Orgovyx is administered orally and stops the pituitary gland from producing certain hormones, which then reduces testosterone production.

The safety and effectiveness of Orgovyx was assessed in a trial with men with advanced prostate cancer who were randomly assigned Orgovyx once per day or leuprolide every three months for 48 weeks. This trial found that patients treated with Orgovyx had a castration rate of 96.7%.

Common side effects with Orgovyx include increased glucose, hot flash, musculoskeletal pain, increased triglycerides, fatigue, decreased hemoglobulin, diarrhea, constipation and increases in certain liver enzymes, according to the release. In addition, health care providers should periodically monitor patients for potentially effects to the heart’s electrical properties or electrolyte abnormalities. The drug may also affect diagnostic test results of gonadal and pituitary gonadotropic functions due to suppression of the pituitary gonadal system.

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