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# Myovant Sciences’ Orgovyx OK’d for Prostate Cancer
- URL: https://www.fdaweb.com/myovant-sciences-orgovyx-okd-for-prostate-cancer/
- Published: 2020-12-18T12:00:00.000Z
- Updated: 2026-09-14T16:40:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148340

FDA has approved Myovant Sciences’ Orgovyx (relugolix) for treating adult patients with advanced prostate cancer. “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,” FDA Oncology Center of Excellence director **Richard Pazdur** is quoted in a [release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-hormone-therapy-treating-advanced-prostate-cancer?ref=fdaweb.com) as saying.

Approval was based on safety and efficacy data that showed Orgovyx achieved and maintained low enough levels of testosterone (castrate levels), by day 29 through the end of the treatment course. In the 622 patients who received Orgovyx, the castration rate was 96.7%, FDA says.

The most common side effects reported included hot flush, increased glucose, increased triglycerides, musculoskeletal pain, decreased hemoglobin, fatigue, constipation, diarrhea and increased levels of certain liver enzymes. “Concurrent use of Orgovyx with drugs that inhibit P-glycoprotein, which plays a role in pumping toxins out of cells, is contraindicated,” the agency says. “Androgen deprivation therapies such as Orgovyx may affect the heart's electrical properties or cause electrolyte abnormalities, therefore healthcare providers should consider periodic monitoring of electrocardiograms and electrolytes.”