Oral Therapy for Patients With Prostate Cancer Granted FDA Approval


Relugolix is the first oral drug in this class to receive FDA approval, and it may eliminate some patients’ need to visit the clinic for certain treatments.

Officials with the FDA have approved relugolix (Orgovyx; Myovant Sciences) for the treatment of adult patients with advanced prostate cancer.

According to Richard Pazdur, MD, director of the 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, relugolix is the first oral drug in this class to receive FDA approval, and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider.

“This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic,” said Pazdur in a prepared statement.

Relugolix is an orally administered treatment that works by blocking the pituitary gland from making luteinizing hormone and follicle-stimulating hormone, which reduces the amount of testosterone the testicles are able to make. Current treatment options for advanced prostate cancer includes androgen deprivation therapies that are injected or placed as small implants under the skin.

The safety and efficacy of relugolix was evaluated in a randomized, open-label trial in men with advanced prostate cancer. The patients randomly received either relugolix once daily or injections of leuprolide, another hormone-targeting drug, every 3 months for 48 weeks. The objective was to determine if relugolix achieved and maintained low enough levels of testosterone, by day 29 through end of the treatment course. According to the FDA, in the 622 patients who received relugolix, the castration rate was 96.7%.

The most common adverse effects of relugolix include hot flush, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea, and increased levels of certain liver enzymes. Androgen deprivation therapies such as relugolix may affect the heart’s electrical properties or cause electrolyte abnormalities. Relugolix can also cause fetal harm and loss of pregnancy when administered to a pregnant female.

The American Cancer Society estimates that in 2020, there will have been more than 190,000 cases of prostate cancer in the United States.


FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer [news release]. Silver Spring, MD; December 18, 2020: FDA. Accessed December 18, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-hormone-therapy-treating-advanced-prostate-cancer

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