FDA Asked to Approve Relugolix to Treat Advanced Prostate Cancer

FDA Asked to Approve Relugolix to Treat Advanced Prostate Cancer
Myovant Sciences has filed an application with the U.S. Food and Drug Administration (FDA) seeking approval of relugolix  to treat men with advanced prostate cancer. The new drug application (NDA) proposes a single daily dose of 120 mg, given as an oral tablet, based on positive results from the Phase 3 HERO trial (NCT03085095, still recruiting in China). “The submission of our NDA for prostate cancer is a major step towards providing a one pill, once a day potential new treatment option for men with advanced prostate cancer,” Lynn Seely, MD, CEO of Myovant Sciences, said in a press release“[W]e believe relugolix, if approved, could provide men an important oral alternative to leuprolide injections, the current standard of care.”  
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