Myovant Sciences announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending the approval of ORGOVYX® (relugolix, 120 mg) for the treatment of adult patients with advanced hormone-sensitive prostate cancer. The European Commission will review the CHMP recommendation, and a final decision on the Marketing Authorization Application is expected to be available in approximately two months. The decision will be applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein.

The CHMP positive opinion recommending approval is supported by efficacy and safety data from the Phase 3 HERO study, a randomized, open-label, parallel-group, multinational clinical study designed to evaluate the safety and efficacy of relugolix compared to leuprolide in over 1,000 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. ORGOVYX® received U.S. Food and Drug Administration approval for the treatment of adult patients with advanced prostate cancer in December 2020. Myovant continues to assess partnership opportunities with multiple interested parties for international commercialization and development rights (excluding Canada and certain Asian countries) to relugolix in prostate cancer.

Myovant remains on track to reach an agreement with a partner by the anticipated EC approval of relugolix for advanced prostate cancer.