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Dec 5

Relugolix Induces Sustained Testosterone Reduction in Advanced PC, Phase 3 Trial Results Show – Prostate Cancer News Today

Testosterone Comments Off on Relugolix Induces Sustained Testosterone Reduction in Advanced PC, Phase 3 Trial Results Show – Prostate Cancer News Today

Treatment with Myovant Sciences relugolix induces a long-lasting reduction in testosterone to castrate levels similar to testosterone levels after medical or chemical castration in nearly all men with advanced prostate cancer who are sensitive to androgen deprivation therapy, updated results from the HERO Phase 3 trial show.In addition to meeting its primary goal sustained castration from weeks 5 to 48 of treatment the trial met six additional secondary goals. These included a faster testosterone suppression than standard treatment with leuprolide acetate, and a rapid drop in prostate specific antigen levels, which are a marker of prostate cancer.The results will support the submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) in the second quarter of 2020, as well as submissions to Japan's and Europe's regulatory agencies.With the exciting results from the HERO study demonstrating the potential of relugolix to provide unique benefits compared to leuprolide, we look forward to submitting an NDA to the FDA, Lynn Seely, MD, president and CEO of Myovant Sciences, said in a press release. We are now closer to our goal of bringing a precision oral medicine to the br

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Relugolix Induces Sustained Testosterone Reduction in Advanced PC, Phase 3 Trial Results Show - Prostate Cancer News Today

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