The FDA approves the first oral hormone therapy to treat advanced prostate cancer

Today, the US 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 patients to visit the clinic for treatments that require administration by a health care provider, said Richard Pazdur, MD, director of the FDA’s Center of Oncological Excellence and interim director of the Office of Cancer Disease at the FDA Center for Drug Evaluation and Research. This potential for reducing 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 United States. One of the treatment options for advanced prostate cancer is androgen deprivation therapy, which uses drugs to reduce hormone levels. Helps prostate cancer cells grow. Current FDA-approved treatments of this type are injected or placed in the form of implants under the skin. Orgovyx is an oral treatment that works by blocking the pituitary gland to produce hormones called luteinizing hormone and follicle-stimulating hormone, thus reducing the amount of testosterone that the testicles are able to produce.

The safety and efficacy of Orgovyx were evaluated in a randomized, open-label study in men with advanced prostate cancer. Patients were randomized to receive either Orgovyx once a day or injections of leuprolide, another hormone-targeted drug, every three months for 48 weeks. The aim was to determine whether Orgovyx had reached and maintained sufficiently low levels of testosterone (castration levels) by day 29 until the end of the course of treatment. Of the 622 patients receiving 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 elevated levels of certain liver enzymes. Androgen deprivation therapies, such as Orgovyx, can affect the electrical properties of the heart or cause electrolyte abnormalities, so healthcare providers should consider regular monitoring of electrocardiograms and electrolytes. Based on the findings in animals and the mechanism of action, Orgovyx may cause fetal injury and miscarriage when administered to a pregnant woman; it is recommended that men with women with reproductive potential use effective contraception during treatment and for two weeks after the last dose of Orgovyx. Due to drug suppression of the pituitary gonadal system, the results of diagnostic tests of pituitary gonadotropic and gonadal functions performed during and after Orgovyx administration may be affected.

The FDA has approved Orgovyx to Myovant Sciences.

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

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