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FDA Approvals, News & UpdatesProstate Cancer

Orgovyx First FDA-Approved Oral Hormone Therapy for Patients with Advanced Prostate Cancer

In December 2020, the FDA approved Orgovyx (relugolix), as the first oral hormone therapy for the treatment of men with advanced prostate cancer. This new drug may eliminate the need to visit the clinic for treatment, helping patients with cancer avoid unnecessary exposure during the pandemic.
February 2021 Vol 7 No 1

In December 2020, the FDA approved Orgovyx (relugolix; from Myovant Sciences), an oral hormone therapy called gonadotropin-releasing hormone (GnRH) receptor antagonist, for the treatment of men with advanced prostate cancer. Orgovyx is the first oral hormone therapy, and the first androgen-deprivation therapy approved for patients with advanced 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 health care provider,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. “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 American Cancer Society estimated that more than 90,000 cases of prostate cancer would be diagnosed in the United States in 2020.

The FDA approved Orgovyx based on the results of a clinical trial of 930 patients with prostate cancer who required at least 1 year of androgen-deprivation therapy because of prostate cancer recurrence after radiation or surgery, or who were newly diagnosed with castration-sensitive advanced prostate cancer.

The patients received 48 weeks of either Orgovyx or another GnRH receptor antagonist, Lupron Depot (leuprolide acetate). The main measure of the benefit of therapy was medical castration, which was defined as maintaining blood testosterone suppression to castrate levels by day 29 through 48 weeks of treatment. Among the 622 patients who received Orgovyx, 97% of them reached medical castration rate, an almost complete efficacy rate, demonstrating the benefit of this new oral therapy.

The most common side effects with Orgovyx were hot flushes, musculoskeletal pain, fatigue, diarrhea, and constipation.

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Last modified: March 3, 2021

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