New Medicines

Advanced prostate cancer - treatment


New molecular entity
Myovant Sciences
Myovant Sciences

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Mar 21Myovant Sciences announce EMA validation of MAA for relugolix for treatment of advanced prostate cancer [14].
Mar 21Considered a potential blockbuster drug for 2021 by analysts. [13]
Jan 21Myovant Sciences intends to submit a marketing authorisation application (MAA) to the EMA for relugolix for prostate cancer in H1 2021 [12].
Jan 21Launched in US [12].
Dec 20The FDA has approved relugolix for the treatment of adult patients with advanced prostate cancer [11].
Jun 20US FDA accept NDA for priority review [9].
Apr 20Myovant submit NDA for for once-daily, oral relugolix (120 mg) for treatment of men with advanced prostate cancer to US FDA [7].
Nov 19Myovant 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 19Myovant plan to file a NDA with US FDA Q2 20 [5].


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

Trial or other data

Oct 20Further data from HERO trial in which relugolix was compared with leuprolide in 934 men with advanced prostate cancer. Though testosterone levels were suppressed more with relugolix, progression was similar. After 48 months, 74% of metastatic patients on relugolix were castration resistance-free vs. 75% of patients on leuprolide. Relugolix is a daily tablet whereas leuprolide, is a quarterly injection [10].
Jun 20The 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 19PIII 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 18PIII HERO trial (NCT03085095) is still recruiting. Collection of primary outcome data is due to complete Dec 19 [4].
Dec 17PIII 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 17PIII 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].