Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today 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.
“This positive CHMP opinion represents another step toward positioning ORGOVYX® as a new standard of care for men with advanced prostate cancer,” said David Marek, Chief Executive Officer of Myovant Sciences, Inc. “We look forward to providing patients and physicians in Europe with the first oral, androgen deprivation therapy treatment to further advance our mission to redefine care for men with prostate cancer.”
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 (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 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.
ABOUT PROSTATE CANCER
Prostate cancer is a leading cause of death in the European Union with about 65,200 men having died from the disease in 2016. The standardized death rate from prostate cancer stood at 38 deaths per 100,000 male inhabitants according to Eurostat.
Prostate cancer is considered advanced when it has spread or come back after initial treatment and may include biochemical recurrence (rising prostate-specific antigen in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels (< 50 ng/dL). Luteinizing hormone-releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, are depot injections and the current standard of care for androgen deprivation therapy. However, LHRH receptor agonists may be associated with mechanism-of-action limitations, including the potentially detrimental initial surge in testosterone levels that can exacerbate clinical symptoms, which is known as clinical or hormonal flare, and delayed testosterone recovery after the drug is discontinued.