FDA Approves ORGOVYX the Only Oral GnRH Receptor Antagonist for Advanced Prostate Cancer
Switzerland based Myovant Sciences Inc. announced that the U.S. FDA approved ORGOVYX™ (relugolix) to treat adult patients with advanced prostate cancer. ORGOVYX, which was granted Priority Review by the FDA, is the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist for men with advanced prostate cancer.
The approval is based on efficacy and safety data from the Phase 3 HERO study of ORGOVYX and is expected to be available in January 2021.
“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., CEO of Myovant Sciences, in a press release.