On December 18, 2020, the Food and Drug Administration approved the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix, (ORGOVYX, Myovant Sciences, Inc.) for adult patients with advanced prostate cancer.
Efficacy was evaluated in HERO (NCT03085095), a randomised, open label trial in men requiring at least one year of androgen deprivation therapy with either prostate cancer recurrence following radiation or surgery or newly diagnosed castration-sensitive advanced prostate cancer.
Patients (N=934) were randomised (2:1) to receive relugolix 360 mg oral loading dose on the first day, followed by daily oral doses of 120 mg, or leuprolide acetate 22.5 mg injection subcutaneously every 3 months for 48 weeks.
The main efficacy outcome measure was medical castration rate defined as achieving and maintaining serum testosterone suppression to castrate levels (< 50 ng/dL) by day 29 through 48 weeks of treatment. The medical castration rate was 96.7% (95% CI: 94.9%, 97.9%) in the relugolix arm.
The most common adverse reactions (≥10%) in patients receiving relugolix in HERO were hot flush, musculoskeletal pain, fatigue, diarrhoea, and constipation.
The most common laboratory abnormalities (≥15%) were increased glucose, triglycerides, alanine aminotransferase, and aspartate aminotransferase.
Decreased haemoglobin was also observed.
The recommended relugolix dose is a loading dose of 360 mg on the first day followed by a daily oral dose of 120 mg at approximately the same time with or without food.
View full prescribing information here.
The World Cancer Declaration recognises that to make major reductions in premature deaths, innovative education and training opportunities for healthcare workers in all disciplines of cancer control need to improve significantly.
ecancer plays a critical part in improving access to education for medical professionals.
Every day we help doctors, nurses, patients and their advocates to further their knowledge and improve the quality of care. Please make a donation to support our ongoing work.
Thank you for your support.