Prostate Cancer Coverage from Every Angle

Relugolix Receives FDA Approval for Advanced Prostate Cancer

By: Jocelyn Solis-Moreira, MS
Posted: Monday, December 21, 2020

On December 18, the U.S. Food and Drug Administration (FDA) approved the first oral gonadotropin-releasing hormone receptor antagonist, relugolix (Orgovyx) for adults with advanced prostate cancer. The recommended relugolix dose is a loading dose of 360 mg on the first day followed by a daily oral dose of 120 mg at approximately the same time with or without food.

The FDA approval was based on results from the open-label HERO trial. A total of 934 men with either newly diagnosed castration-sensitive advanced prostate cancer or prostate cancer recurrence following at least 1 year of androgen-deprivation therapy were recruited into the trial. Patients were randomly assigned a 360-mg loading dose of relugolix on the first day, followed by daily oral doses of 120 mg of relugolix, or a 22.5-mg subcutaneous injection of leuprolide acetate every 3 months for 48 weeks.

The main efficacy outcome measure was the medical castration rate, defined as achieving and maintaining serum testosterone suppression to castrate levels (< 50 ng/dL) by day 29 through 48 weeks of treatment. The medical castration rate was 96.7% (95% confidence interval = 94.9%–97.9%) in the relugolix arm.

The most common adverse reactions observed in more than 10% of patients receiving relugolix were hot flush, musculoskeletal pain, fatigue, diarrhea, and constipation. The most common laboratory abnormalities in 15% or more of patients were increased glucose, triglycerides, alanine aminotransferase, and aspartate aminotransferase. Researchers also observed a decrease in hemoglobin.

For full prescribing information on relugolix, visit

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