CHMP recommends Orgovyx to treat advanced hormone sensitive prostate cancer.-Myovant Sciences.
Myovant Sciences announced that the Committee for Medicinal Products for Human Use (CHMP) 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 (EC) 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. Orgovyx is the first oral, androgen deprivation therapy treatment for prostate cancer.
The CHMP positive opinion recommending approval is supported by efficacy and safety data from the Phase III 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 FDA 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).
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