For immediate release:

Today, the United States Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer.

“Today’s approval marks the first oral drug in this class and may eliminate the need for some patients to come to the clinic for treatments that require administration by a health care provider,” said Richard Pazdur, MD, director of the FDA Center of Excellence in Oncology and Acting Director of the Office of Oncological Diseases at the FDA Center for Drug Evaluation and Research. “This potential for reduced clinic visits may be particularly beneficial in helping cancer patients stay home and avoid exposure during the coronavirus pandemic.”

The American Cancer Society estimates that by 2020 there will be more than 190,000 cases of prostate cancer in the U.S. One of the treatment options for advanced prostate cancer is withdrawal therapy. androgen, which drugs use to reduce levels of hormones that help prostate cancer. cells are growing. Current FDA-approved treatments of this type are injected or placed as small implants under the skin. Orgovyx is an oral treatment that works by preventing the pituitary gland from making hormones called luteinizing hormone and follicle stimulating hormone, thereby reducing the amount of testosterone the testes are able to produce.

The safety and efficacy of Orgovyx has been evaluated in an open randomized trial in men with advanced prostate cancer. Patients were randomly given either Orgovyx once a day or injections of leuprolide, another drug that targets hormones, every three months for 48 weeks. The aim was to find out if Orgovyx was achieving and maintaining sufficiently low testosterone levels (castration rate) from day 29 until the end of treatment. In the 622 patients who received Orgovyx, the castration rate was 96.7%.

The most common side effects of Orgovyx include: hot flashes, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea, and increased levels of certain liver enzymes. Androgen deprivation therapies such as Orgovyx may affect the electrical properties of the heart or cause electrolyte abnormalities, therefore healthcare providers should consider periodic monitoring of EKGs and electrolytes. Based on animal findings and mechanism of action, Orgovyx can cause fetal damage and pregnancy loss when given to a pregnant woman; Men with female partners of childbearing potential are advised to use effective contraception during treatment and for two weeks after the last dose of Orgovyx. Due to the suppression of the pituitary gonadal system by the drug, the results of diagnostic tests for gonadotropic and pituitary gonadal function performed during and after taking Orgovyx may be affected.

The FDA has granted Orgovyx approval to Myovant Sciences.

The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines and other biologicals for human use, and medical devices . The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, products emitting electronic radiation and the regulation of tobacco products.

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