Relugolix, the first oral hormone therapy for advanced prostate cancer (PCa), received Food and Drug Administration (FDA) approval today.

The agency based its approval on a randomized, open-label trial that included men with advanced PCa randomly assigned to receive relugolix (Orgovyx; Myovant Sciences) once daily or injections of leuprolide every 3 months for 48 weeks. In the patients who received relugolix, the castration rate was 96.7%, according to an FDA press release. The most common side effects from the drug included hot flushes, elevated glucose levels, increased triglyceride levels, decrease hemoglobin levels, musculoskeletal pain, fatigue, constipation, and diarrhea, the press release noted.

“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 FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic.”

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FDA approves first oral hormone therapy for treating advanced prostate cancer. FDA press release. December 18, 2020.