Orgovyx First Oral Hormone Therapy Approved for Advanced Prostate Cancer

On December 18, 2020, the FDA approved the oral gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix (Orgovyx; Myovant Sciences), for the treatment of adult patients with advanced prostate cancer. As an GnRH receptor, relugolix reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.

“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 healthcare provider,” Richard Pazdur, MD, Director of FDA’s Oncology Center of Excellence, said in a press release. “This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic.”

The approval of relugolix for this indication was based, in part, on results from a phase 3 clinical trial of men with advanced prostate cancer. Patients in this trial were randomized to relugolix once daily or injections of the hormone-targeting drug leuprolide every 3 months for 48 weeks. The objective of the study was to determine whether relugolix achieved and maintained low enough levels of testosterone (castrate levels), by day 29 through the end of the treatment course. In the 622 patients in the relugolix arm, the castration rate was 96.7%.

The most common (≥10%) adverse reactions reported among relugolix-treated patients included hot flush (54%), musculoskeletal pain (30%), fatigue (26%), constipation (12%), and diarrhea (12%).

The FDA previously granted relugolix a priority review for this indication.

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