Recently, Myovant Sciences announced that its new drug application (NDA) for innovative therapy relugolix has been accepted by the US FDA, and the indication is for male patients with advanced prostate cancer. The FDA also granted this NDA priority review qualification and is expected to respond by December 20 this year. The FDA also stated in the acceptance letter that it currently does not plan to hold an advisory committee meeting for this application. If approved, relugolix will be the first and only oral gonadotropin-releasing hormone (GnRH) receptor antagonist to treat patients with advanced prostate cancer.
Prostate cancer is the second most common cancer in men in the world. It is estimated that in 2018, there were 1.2 million new patients and about 360,000 patients died as a result. Prostate cancer is the fifth leading cause of cancer death in men. For patients with castration-sensitive prostate cancer, standard treatment includes gonadotropin-releasing hormone (GnRH) agonist leuprolide acetate. However, this therapy may cause a transient increase in testosterone levels, exacerbate clinical symptoms, and delay the recovery of testosterone levels after drug withdrawal.
Relugolix is an oral GnRH receptor antagonist that can bind to and block GnRH receptors in the anterior pituitary and reduce the release of luteinizing hormone (LH) and follicle stimulating hormone (FSH), thereby reducing female ovarian production. Estrogen levels and testosterone production in men.
Myovant Sciences is developing relugolix single drug tablets for the treatment of advanced prostate cancer and relugolix combination tablets for the treatment of uterine fibroids. In May this year, Myovant Sciences has submitted a new drug application for relugolix combination tablets to treat uterine fibroids.