Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 120 mg) |
Drug Class | Gonadotropin-releasing hormone receptor antagonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adult patients with advanced prostate cancer.
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Summary
- Orgovyx (relugolix) is indicated for the treatment of adult patients with advanced prostate cancer.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). 3. 12-Month Castration Rate: Relugolix had a risk ratio (RR) of 1.09 (95% CrI: 0.95-1.23) and Degarelix had a RR of 0.98 (95% CrI: 0.91-1.06) compared to GnRH agonists, indicating no significant difference in achieving the 12-month castration rate. However, the 480 mg dose of degarelix was significantly associated with a lower castration rate (RR 0.46, 95% CrI: 0.07-0.92). [1-2]
- Comparative Effectiveness: Relugolix and degarelix were comparable in achieving the 12-month castration rate, with relugolix showing a slight, non-significant edge in efficacy ranking analyses.
- Subgroup Analysis: A significant finding was noted for the 480 mg dose of degarelix, which had a lower 12-month castration rate compared to other doses. No specific population types were mentioned in the subgroup analyses.
- GnRH antagonists (relugolix and degarelix) were associated with significantly fewer adverse cardiovascular events, cardiovascular deaths, and all-cause mortality compared to GnRH agonists, with pooled risk ratios of 0.57 (95% CI: 0.39-0.81), 0.49 (95% CI: 0.25-0.96), and 0.48 (95% CI: 0.28-0.83), respectively.
- Relugolix and degarelix demonstrated no significant differences in overall adverse events and serious adverse events when compared to GnRH agonists, with relugolix having RRs of 0.99 (95% CrI: 0.6-1.6) for all AEs and 0.72 (95% CrI: 0.4-1.3) for serious AEs, and degarelix having RRs of 1.1 (95% CrI: 0.75-1.35) for all AEs and 1.05 (95% CrI: 0.42-2.6) for serious AEs.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Orgovyx (relugolix) Prescribing Information. | 2022 | Myovant Sciences, Inc., Brisbane, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
The cardiovascular effects of gonadotropin-releasing hormone antagonists in men with prostate cancer. | 2022 | European Heart Journal. Cardiovascular Pharmacotherapy |
The efficacy and safety of relugolix compared with degarelix in advanced prostate cancer patients: a network meta-analysis of randomized trials. | 2022 | European Urology Oncology |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Relugolix in clinical practice: the best route for all? | 2023 | Oncologist |