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Orgovyx FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved December 18, 2020)
Brand name: Orgovyx
Generic name: relugolix
Dosage form: Tablets
Company: Myovant Sciences
Treatment for: Prostate Cancer

Orgovyx (relugolix) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.

Development timeline for Orgovyx

Dec 18, 2020Approval FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer
Sep 29, 2020Myovant Sciences Announces Results of Additional Secondary Endpoint of Castration Resistance-Free Survival from Phase 3 HERO Study of Relugolix in Advanced Prostate Cancer
Jun 22, 2020Myovant Sciences Announces Priority Review and FDA Acceptance of New Drug Application for Once-Daily, Oral Relugolix for Advanced Prostate Cancer
May 29, 2020Sumitovant Biopharma Announces Myovant Sciences’ Additional Positive Efficacy and Cardiovascular Safety Data from Phase 3 HERO Study of Once-Daily, Oral Relugolix in Advanced Prostate Cancer and Publication in the New England Journal of Medicine
Nov 19, 2019Myovant Sciences Announces 97% Response Rate in Positive Phase 3 HERO Study of Once-Daily, Oral Relugolix in Men with Advanced Prostate Cancer

Further information

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