On 18 December 2020, the US Food and Drug Administration (FDA) approved the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist, relugolix, (ORGOVYX, Myovant Sciences, Inc.) for adult patients with advanced prostate cancer.<\/p>\n
Efficacy was evaluated in HERO (NCT03085095), a randomised, open label study 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.<\/p>\n
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% confidence interval [CI] 94.9%, 97.9%) in the relugolix arm.<\/p>\n
The most common adverse reactions (\u226510%) in patients receiving relugolix in HERO were hot flush, musculoskeletal pain, fatigue, diarrhoea, and constipation. The most common laboratory abnormalities (\u226515%) were increased glucose, triglycerides, alanine aminotransferase, and aspartate aminotransferase. Decreased haemoglobin was also observed.<\/p>\n
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.<\/p>\n
Full prescribing information for ORGOVYX is available here<\/a>.<\/p>\n This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA\u2019s assessment.<\/p>\n This application was granted priority review.<\/p>\n Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA\u2019s MedWatch Reporting System.<\/p>\n For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA\u2019s Oncology Center of Excellence<\/a> Project Facilitate<\/a>.<\/p>\n