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FDA Approves First Oral Hormone Therapy for Advanced Prostate Cancer

MONDAY, Dec. 21, 2020 -- Orgovyx (relugolix) is now approved to treat advanced prostate cancer and is the first oral hormone therapy approved for this indication, the U.S. Food and Drug Administration announced Friday.

As opposed to currently approved hormone therapies that are injected or placed as implants under the skin, Orgovyx is administered orally and works by blocking the pituitary gland from producing luteinizing hormone and follicle-stimulating hormone.

Researchers evaluated the safety and efficacy of Orgovyx in the phase 3 HERO study, a randomized, open-label trial in prostate cancer patients randomly assigned to either Orgovyx once a day or leuprolide injections every three months for 48 weeks. Among the 622 patients who received Orgovyx, 96.7 percent achieved and maintained castrate levels of testosterone (<50 ng/dL) by day 29 through the end of treatment compared with 88.8 percent of men who received leuprolide acetate injections.

The most commonly reported side effects of Orgovyx included hot flush, increased glucose and triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea, and increased liver enzyme levels. The FDA notes that Orgovyx, like other androgen deprivation therapies, may affect the heart's electrical properties or cause electrolyte abnormalities. Health care providers should consider periodically monitoring electrocardiograms and electrolytes.

Approval was granted to Myovant Sciences. The company said in a statement that it expects Orgovyx to be available in January.

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Posted: December 2020

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