FDA Approves Orgovyx, Oral ADT for Advanced Prostate Cancer

FDA Approves Orgovyx, Oral ADT for Advanced Prostate Cancer
The U.S. Food and Drug Administration (FDA) has approved Orgovyx (relugolix), an oral form of hormone therapy by Myovant Sciences, to treat adults with advanced prostate cancer. The approval, granted under priority review, was based on data from the HERO Phase 3 trial (NCT03085095), in which Orgovyx significantly increased the proportion of patients with sustained reductions in testosterone levels over nearly one year, compared with standard-of-care leuprolide acetate. Treatment also lowered the risk of major cardiovascular events by more than half. With this decision, Orgovyx is now the first and only oral gonadotrophin-releasing hormone (GnRH) receptor inhibitor to win regulatory approval in the U.S. for this indication. According to Myovant, Orgovyx is expected to be commercially available in January. “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,” Lynn Seely, MD, CEO of Myovant Sciences, said in a press release. To help those prescribed Orgovyx, Myovant is launching the Orgovyx Patient Support Program. Through that program, patients will have access to a free trial of the therapy for up to two months, help with verification of insurance plans, copay support for commercially insured patients, and assistance for uninsured patients. More information on the program is available by calling the 833-674-6899 Monday through Friday, 8 a.m. to 8 p.m. ET. "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,” Seely added. Orgovyx is a small molecule inhibitor of the Gn
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