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…
April 25, 2020April 25, 2020