On April 29, 2022 Myovant Sciences (NYSE: MYOV) reported that the European Commission (EC) has approved the marketing authorisation application for ORGOVYX (relugolix, 120 mg) for the treatment of adult patients with advanced hormone-sensitive prostate cancer (Press release, Myovant Sciences, APR 29, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-european-commission-approval-orgovyxr [SID1234613230]). The approval is applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein.
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"Now for the first time, patients in Europe have the ability to rapidly reduce testosterone without hormonal flare in a convenient oral form," said Juan Camilo Arjona Ferreira, Chief Medical Officer of Myovant Sciences, Inc. "This approval provides a valuable new treatment option for men with advanced hormone-sensitive prostate cancer in Europe and has the potential to change the standard of care over time."
"We’ve made significant progress in securing a business partner for the commercialization of ORGOVYX in Europe. We’ve had interest from multiple parties and anticipate an announcement in the upcoming weeks, in advance of the anticipated launches in European markets," said David Marek, Chief Executive Officer, Myovant Sciences, Inc.
This approval was supported by 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. The study compared relugolix 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.
In the 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. ORGOVYX also achieved several key secondary endpoints compared to leuprolide acetate, including suppression of testosterone to castrate levels at Day 4 and Day 15 (56% versus 0% and 99% versus 12%, respectively) and profound suppression of testosterone (< 20 ng/dL) at Day 15 (78% versus 1%). The most frequent adverse events reported in at least 10% of men in the ORGOVYX group were hot flush, musculoskeletal pain, fatigue, constipation, and mild to moderate diarrhea. The HERO data were previously presented in an oral presentation at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program, with simultaneous publication in The New England Journal of Medicine.
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.
About ORGOVYX (relugolix)
ORGOVYX (relugolix, 120 mg) is indicated in Europe for the treatment of adult patients with advanced hormone-sensitive prostate cancer. As a GnRH antagonist, ORGOVYX blocks the GnRH receptor and reduces production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.