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HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

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Trial Profile

HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Feb 2024

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At a glance

  • Drugs Relugolix (Primary) ; Leuprorelin
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms HERO
  • Sponsors Myovant Sciences

    • Most Recent Events

    • 23 Oct 2023 According to a Sumitomo Pharma Canada media release, the Health Canada has approved relugolix for the treatment of men with advanced prostate cancer. The approval is based on efficacy and safety data from this study. ORGOVYX is expected to be available for prescription in Canada in Q1 2024.
    • 15 Sep 2023 Results of Subgroup Analysis characterizing the impact of concomitant CV therapies on efficacy and safety, published in the Advances in Therapy
    • 27 Jul 2022 According to a Myovant Sciences media release, the company expects to submit New Drug Submissions to Health Canada seeking marketing approval for ORGOVYX for advanced prostate cancer second half of calendar year 2022.
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