Myovant Sciences Ltd (MYOV)

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Myovant Sciences announces FDA approval of ORGOVYX as treatment for adult patients with advanced prostate cancer

12/18/20 | Briefing.com
The FDA has approved ORGOVYX (relugolix) for the treatment of adult patients with advanced prostate cancer. ORGOVYX, which was granted Priority Review by the FDA, is the first and only oral gonadotropin-releasing hormone receptor antagonist for men with advanced prostate cancer. The approval is based on efficacy and safety data from the Phase 3 HERO study of ORGOVYX in men with advanced prostate cancer. ORGOVYX is expected to be available in January 2021.In the Phase 3 HERO study, ORGOVYX met the primary endpoint and achieved sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks in 96.7% (95% confidence interval [CI]: 94.9-97.9) of men, compared with 88.8% (95% CI: 84.6-91.8) of men receiving leuprolide acetate injections, the current standard of care.Myovant will hold a conference call on December 21 at 8:30 a.m. ET to discuss the FDA approval of ORGOVYX for men with advanced prostate cancer.