Dr. Shore on the FDA Approval of Relugolix in Advanced Prostate Cancer

Neal D. Shore, MD, FACS, discusses the approval of relugolix in advanced prostate cancer.

Neal D. Shore, MD, FACS, medical director of the Carolina Urologic Research Center, discusses the approval of relugolix (Orgovyx) in advanced prostate cancer.

On December 18, 2020, the FDA approved relugolix, a gonadotropin-releasing hormone receptor antagonist, for the treatment of patients with advanced prostate cancer.

The approval is based on findings from the phase 3 HERO trial, in which relugolix demonstrated superior sustained testosterone-suppression through 48 weeks, fast testosterone recovery after discontinuation, and a 50% reduction in major adverse cardiovascular events compared with leuprolide (Lupron) in this patient population.

According to Shore, the ability to offer patients an additional treatment option is welcomed.

Moreover, oral agents such as relugolix have the potential to spare patients mandatory trips to the clinic, says Shore. Additionally, treatment with relugolix may minimize the risks associated with receiving treatment in person, particularly given the coronavirus disease 2019 pandemic.

Additionally, relugolix may be a convenient option for patients as it is a once-a-day regimen where patients see their urologist, medical oncologist, or radiation oncologist when clinical evaluation is warranted, concludes Shore.