FDA Approves Myovant Sciences’ ORGOVYX (relugolix), the First and Only Oral GnRH Receptor Antagonist for Advanced Prostate Cancer

The FDA has announced it has granted approval to Myovant Sciences for OrgovyxTM (relugolix) in the treatment of adult patients with advanced prostate cancer. Patients with advanced prostate cancer being treated with androgen deprivation therapy now have a once-daily oral treatment.  Orgovyx, an oral therapy, reduce the secretion of the hormone, testosterone, by blocking the pituitary gland from making hormones called luteinizing hormone and follicle-stimulating hormone. Richard Pazdur, M.D., the Director of the FDA's Oncology Center of Excellence, said, “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."  The approval was based on the results of a randomized, open-label trial in men with advanced prostate cancer where 622 patients who received Orgovyx achieved and maintained 96.7% of castration rate (low enough levels of testosterone) by day 29.

“With the approval of ORGOVYX, men with advanced prostate cancer now have a new oral treatment option that has demonstrated robust efficacy and safety, all with one pill taken once-a-day,” said Lynn Seely, M.D., chief executive officer of Myovant Sciences, Inc. “We have successfully built our commercial capabilities to bring this newly approved treatment to the urologists and oncologists who care for men with advanced prostate cancer with the goal of establishing ORGOVYX as the new standard of care. We are incredibly grateful to the men and investigators who participated in the HERO study and to the FDA for expediting the review and approval of ORGOVYX through its Priority Review pathway.” 
The currently approved therapies of his type for prostate cancer are injected or placed as small implants under the skin. Patients no longer will need to schedule depot injections at their physician's offices.   “I am enormously pleased by the approval of ORGOVYX and believe it has the potential to usher in a new standard of care for men with prostate cancer requiring androgen deprivation therapy,” said Neal Shore, M.D., medical director of the Carolina Urologic Research Center and HERO program steering committee member. “For the first time, we now have a once-daily oral treatment that effectively and rapidly suppresses testosterone. The COVID-19 pandemic has heightened the importance of oral treatments as men with prostate cancer continue to experience difficulties and risks traveling to receive injections.”