Prostate Cancer Coverage from Every Angle
Advertisement
Advertisement

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 accessdata.fda.gov.



By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.