For immediate release:

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

“Today’s agreement marks the first oral drug in this class and may eliminate the need for some patients to visit the clinic for treatments that require administration by a healthcare provider. , ”Said Richard Pazdur, MD, director of the FDA’s Center of Oncology Excellence and executive director of the Office of Oncologic Diseases at the FDA’s Center for Drug Assessment and Research. “This ability to reduce clinic visits can be particularly beneficial in helping cancer patients stay at home and avoid exposure during pandemic coronavirus infection.”

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 androgen deficiency, which uses drugs to lower levels of the hormones that help prostate cancer. cells grow. Conventional treatments of this type that have been approved by the FDA are injected or placed as small implants under the skin. Orgovyx is an orally administered treatment that works by blocking the pituitary gland from producing hormones called luteinizing hormone and follicle stimulating hormone, thus reducing the amount of testosterone that is present. the testicles are able to do.

The safety and efficacy of Orgovyx were evaluated in a randomized, open-label trial in men with advanced prostate cancer. The patients were randomly given either Orgovyx once a day or an injection of leuprolide, another hormone-targeting drug, every three months for 48 weeks. The goal was to determine whether Orgovyx was performing and maintaining sufficiently low levels of testosterone (castrate levels), by day 29 through the end of the course 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, muscle pain, decreased hemoglobin, muscle weakness, asthma, diarrhea and elevated levels of some liver enzymes. Androgen deficiency medications such as Orgovyx can affect the heart ‘s electrical characteristics or cause electrolyte disorders, so healthcare providers should consider periodic monitoring of electrocardiograms and electrolytes. Based on results in animals and their mode of action, Orgovyx can cause fetal damage and loss of pregnancy 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. As a result of the drug’s infiltration of the pituitary gonadal system, diagnostic test results of the gonadotropic and gonadal pituitary functions performed during and after taking Orgovyx may be affected.

The FDA approved Orgovyx to Myovant Sciences.

The FDA, an agency within the U.S. Department of Health and Human Services, protects public health by determining the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for use. human, and medical devices. The organization is also responsible for the safety and security of our country’s food supply, cosmetics, dietary products, products that emit electronic radiation, and for the regulation of tobacco products.