Relugolix (Orgovyx), a GnRH antagonist, approved for advanced disease
by Ian Ingram, Deputy Managing Editor, MedPage Today December 18, 2020
WASHINGTON — The FDA on Friday approved relugolix (Orgovyx), an oral androgen deprivation therapy (ADT) for men with advanced prostate cancer.
“Today’s approval marks the first oral drug in this class and it may eliminate some patients’ need to visit the clinic for treatments that require administration by a health care provider,” Richard Pazdur, MD, the FDA’s top oncology/hematology official, said in a statement. “This potential to reduce clinic visits can be especially beneficial in helping patients with cancer stay home and avoid exposure during the coronavirus pandemic.”
Approval was based on findings from the open-label phase III HERO study, which included 930 men with advanced prostate cancer.
From day 29 to week 48, castration levels were maintained in 96.7% of those assigned to relugolix, a gonadotropin-releasing hormone (GnRH) antagonist, compared to 88.8% of those on leuprolide, a GnRH agonist delivered via injection, meeting prespecified criteria for both non-inferiority and superiority (P<0.001).
Risk of serious heart events were also reduced with relugolix in the study. Cumulative incidence of major adverse cardiovascular events at 48 weeks (non-fatal stroke or myocardial infarction, or death from any heart-related cause) was 2.9% with the oral drug versus 6.2% with leuprolide (HR 0.46, 95% CI 0.24-0.88).
Common side effects with relugolix in the HERO study included constipation; diarrhea; fatigue; hot flashes; increased glucose, triglycerides, and liver enzymes; decreased hemoglobin; and musculoskeletal pain.
FDA recommends “periodic monitoring of electrocardiograms and electrolytes,” for patients on the drug due to ADT treatments’ effect on electrical properties in the heart and their ability to cause electrolyte abnormalities. The agency also recommended contraception during and for 2 weeks following treatment.
Last Updated December 18, 2020
Ian Ingram joined MedPage Today in 2018 as Deputy Managing Editor, and covers oncology for the site.