Enrollment completed in HERO trial of relugolix for the treatment of men with advanced prostate cancer.- Myovant Sciences

Myovant Sciences announced it has completed patient enrollment in its pivotal Phase III clinical trial, HERO, which is evaluating the safety and efficacy of relugolix for the treatment of men with advanced prostate cancer. The HERO study is designed to support approval by FDA, the European Medicines Agency (EMA) and the Japanese Pharmaceuticals and Medical Devices Agency.

Pending positive Phase III results in HERO trial, Myovant expects to submit a New Drug Application for relugolix with the FDA in early 2020. If approved, relugolix has the potential to be the first oral GnRH receptor antagonist approved for the treatment of advanced prostate cancer. Relugolix is administered as one pill once-daily and has been shown to decrease testosterone and PSA levels within days in Phase 1 and II clinical studies.