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FDA Approval

FDA Approves Relugolix for Advanced Prostate Cancer

December 18, 2020

On December 18, 2020, the FDA granted approval to relugolix (Orgovyx, Myovant Sciences) for the treatment of adult patients with advanced prostate cancer. Relugolix is the first oral hormone therapy approved by the FDA for the treatment of advanced prostate cancer.

This approval is based on safety and efficacy results from a randomized, open-label trial, in which patients were randomized to receive relugolix once daily or leuprolide every 3 months for 48 weeks.

The primary study aim was achievement and maintenance of low enough levels of testosterone, by day 29 through end of the treatment course with relugolix.

Among 622 patients who received relugolix, the castration rate was 96.7%.

The most common adverse events associated with relugolix include hot flush, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea and increased levels of certain liver enzymes.—Janelle Bradley

Source: US Food and Drug Administration. FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer. December 18, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-hormone-therapy-treating-advanced-prostate-cancer. Accessed December 18, 2020.

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