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    Association details:
    Biomarker:No biomarker
    Cancer:Prostate Cancer
    Drug:Orgovyx (relugolix) (GnRH antagonist)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    12/18/2020
    Excerpt:
    ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.
    Trial ID:
    HERO
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Prostate cancer: PRINCIPLES OF ANDROGEN DEPRIVATION THERAPY...ADT for Regional (N1,M0) Disease…Options for ADT are: LHRH antagonist...Degarelix, relugolix
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ASCO 2022
    Title:

    Efficacy and safety of relugolix in men with advanced prostate cancer based on baseline body mass index (BMI): A subgroup analysis from the randomized, phase 3 HERO study versus leuprolide (LEU).

    Published date:
    05/26/2022
    Excerpt:
    Of the 930 men (relugolix:622; LEU:308) treated in HERO, 287 (30.9%) men had BMI <25, 424 (45.6%) were 25 – 29.9, 219 (23.5%) were >29.9. Sustained castration rates through 48 weeks were higher for the relugolix group than the LEU group and results for select key secondary endpoints were generally consistent across BMI categories, although PSA response proportions were lower in obese patients.In this HERO study subgroup analysis, relugolix demonstrated greater continuous T suppression than LEU regardless of baseline BMI.
    DOI:
    10.1200/JCO.2022.40.16_suppl.5073
    Trial ID:
    HERO
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Myovant Press Release
    Title:

    Myovant Sciences Receives Positive CHMP Opinion for ORGOVYX® (relugolix) for the Treatment of Advanced Prostate Cancer

    Published date:
    02/25/2022
    Excerpt:
    Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the approval of ORGOVYX® (relugolix, 120 mg) for the treatment of adult patients with advanced hormone-sensitive prostate cancer....The CHMP positive opinion recommending approval is supported by efficacy and safety data from the Phase 3 HERO study...
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Myovant Press Release
    Title:

    Myovant Sciences Announces Priority Review and FDA Acceptance of New Drug Application for Once-Daily, Oral Relugolix for Advanced Prostate Cancer

    Published date:
    06/22/2020
    Excerpt:
    ...Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that its New Drug Application (NDA) for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer has been accepted for Priority Review by the U.S. Food and Drug Administration (FDA).
    Evidence Level:
    Sensitive: B - Late Trials
    New
    Source:
    N Engl J Med
    Title:

    Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer

    Excerpt:
    All other key secondary end points showed superiority of relugolix over leuprolide (P<0.001). The percentage of patients with castrate levels of testosterone on day 4 was 56.0% with relugolix and 0% with leuprolide....this trial involving men with advanced prostate cancer, relugolix achieved rapid, sustained suppression of testosterone levels that was superior to that with leuprolide, with a 54% lower risk of major adverse cardiovascular events.
    DOI:
    10.1056/NEJMoa2004325
    Trial ID:
    HERO