FDA Asked to Approve Relugolix to Treat Advanced Prostate Cancer

FDA Asked to Approve Relugolix to Treat Advanced Prostate Cancer
Myovant Sciences has filed an application with the U.S. Food and Drug Administration (FDA) seeking approval of relugolix  to treat men with advanced prostate cancer. The new drug application (NDA) proposes a single daily dose of 120 mg, given as an oral tablet, based on positive results from the Phase 3 HERO trial (NCT03085095, still recruiting in China). “The submission of our NDA for prostate cancer is a major step towards providing a one pill, once a day potential new treatment option for men with advanced prostate cancer,” Lynn Seely, MD, CEO of Myovant Sciences, said in a press release. “[W]e believe relugolix, if approved, could provide men an important oral alternative to leuprolide injections, the current standard of care.”   Treatment for advanced prostate cancer typically involves androgen deprivation therapy (ADT), which lowers blood levels of testosterone — a hormone known to stimulate the growth of prostate cancer. These reduced levels (below 50 nanograms per microliter of blood) are commonly referred to as castrate levels. Common ADTs come with limitations. An example is leuprolide acetate (marketed under the brand names Eligard and Lupron), which may cause an initial rise in testosterone levels that can worsen symptoms and delay testosterone recovery.  Such therapies also require regular injections. Relugolix is a different form of hormone therapy, as it blocks the gonadotropin-releasing hormone (GnRH) receptor in the brain to inhibit the release of hormones that stimulate testicular testosterone production. The global HERO trial was designed to evaluate whether relugolix outperforms standard leuprolide acetate at lowering testosterone to castrate levels in men whose advanced prostate cancer is sensitive to ADT. R
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