Myovant Sciences (NYSE:MYOV) has announced that the US FDA has granted ORGOVYX™ (relugolix) approval for the treatment of advanced prostate cancer patients. ORGOVYX received Priority Review from the agency and it becomes the first and only approved oral gonadotropin-releasing hormone receptor antagonist for advanced prostate cancer patients.
ORGOVYX receives approval from FDA
The FDA granted the approval based on safety and efficacy data from ORGOVYX’s Phase 3 HERO study in advanced prostate cancer patients. The company expects to avail ORGOVYX to patients in January 2021.
HERO study steering committee member, Neal Shore said that they are delighted with the approval of ORGOVYX. Neal said that this means that there is the potential of ushering in a new standard of care treatment for prostate cancer patients that require androgen deprivation therapy. He added that for the first time there is a once-daily oral that rapidly and effectively suppresses testosterone. Safety analysis of ORGOVYX has shown a low incidence of major adverse cardiovascular events relative to leuprolide injections, which is the current standard of care. Neal added that the pandemic heightened the need for oral treatment as prostate cancer patients continue to face challenges and risks of traveling to get the injections.
New oral treatment for advanced prostate cancer patients
Founder and President of Prostate Health Education Network, Thomas Farrington stated that prostate cancer is a personal journey and patients need better treatments and alternatives. Thomas said that ORGOVYX’s approval is a massive milestone that will deliver the long-awaited oral treatment alternative for advanced prostate cancer patients. He added that it vital for men to speak with physicians to explore the ideal treatment alternative for them
Myovant Sciences CEO, Lynn Seely said that the approval for ORGOVYX means that advanced prostate cancer patients now have a once-daily oral treatment alternative that has shown strong efficacy and safety. Seely said that the company has successfully built its commercial capabilities to deliver the newly approved treatment to oncologists and urologists that care for advanced prostate cancer patients. ORGOVYX met its primary endpoint in the Phase 3 ERO study.