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FDA Approves Relugolix for Advanced Prostate Cancer

Efficacy was evaluated in HERO study
07 Jan 2021
Anticancer agents & Biologic therapy;  Genitourinary cancers

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.

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.

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.

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.

Full prescribing information for ORGOVYX is available here.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted priority review.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA’s Oncology Center of Excellence Project Facilitate.

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