Relugolix

Unassigned

New Medicines

Advanced prostate cancer - treatment

Information

New molecular entity
Myovant Sciences
Myovant Sciences

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Pre-registration (Filed)
Jun 20 · US FDA accept NDA for priority review [9].
Apr 20 · Myovant submit NDA for for once-daily, oral relugolix (120 mg) for treatment of men with advanced prostate cancer to US FDA [7].
Nov 19 · Myovant has completed the European Scientific Advice procedure supporting the design of the HERO trial for approval in the EU should it be successful [6].
Nov 19 · Myovant plan to file a NDA with US FDA Q2 20 [5].

Category

GnRH antagonist
Prostate cancer is the most common cancer in men and makes up 26% of all male cancer diagnoses in the UK. The age-standardised incidence of prostate cancer in the UK in 2014 was 175 per 100,000 population and the lifetime risk of the diagnosis in 2012 in the UK was 1 in 8 [2].
Advanced prostate cancer - treatment
Oral

Trial or other data

Jun 20 · The PIII HERO study (n=930) is published; relugolix was associated with superior suppression of testosterone levels to castrate levels through 48 weeks (96.7% v 88.8% with leuprolide; P<0.001 for superiority) [8].
Nov 19 · PIII HERO trial meets primary outcome. Relugolix was non-inferior to leuprorelin for achieving sustained testosterone suppression to castrate levels at 48 weeks. Pharmacodynamic results also showed no testosterone flare after initiation of relugolix [5].
Nov 18 · PIII HERO trial (NCT03085095) is still recruiting. Collection of primary outcome data is due to complete Dec 19 [4].
Dec 17 · PIII HERO trial (NCT03085095) is still recruiting. Collection of primary outcome data (Sustained castration rate defined as the cumulative probability of testosterone suppression to ≤50ng/dL or 1.7nmol/L while on study treatment from Week 5 through Week 48) is due to complete Sep 19 [3].
Mar 17 · PIII trial (HERO) starts to evaluate the safety and efficacy of relugolix in men with androgen-sensitive advanced prostate cancer who require at least one year of continuous androgen deprivation therapy. Approximately 1,125 patients America, Europe, and Asia-Pacific regions will be involved, those enrolled in the study will be randomized 2:1 to receive oral relugolix 120 mg once daily or leuprolide acetate 3-month depot injection [1].