Myovant Sciences Announces European Commission Approval for ORGOVYX® (relugolix) for the Treatment of Advanced Hormone-Sensitive Prostate Cancer

  • ORGOVYX® is the first and only oral androgen deprivation therapy for advanced hormone-sensitive prostate cancer in Europe
  • Myovant expects to secure European commercialization partner ahead of anticipated launches

BASEL, Switzerland I April 29, 2022 I Myovant Sciences (NYSE: MYOV) today announced 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. The approval is applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein.

“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) 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.

About Myovant Sciences 
Myovant Sciences is a healthcare company focused on redefining care through differentiated solutions in high unmet need areas within women’s health and hormone-sensitive oncology. Founded in 2016, Myovant has executed five successful Phase 3 clinical trials across oncology and women’s health leading to two regulatory approvals by the U.S. Food and Drug Administration (FDA) for men with advanced prostate cancer and women with heavy menstrual bleeding associated with uterine fibroids, respectively. The company also has received regulatory approvals by the European Commission (EC) for women with symptomatic uterine fibroids and for men with advanced hormone-sensitive prostate cancer. The company has a supplemental New Drug Application in endometriosis-associated pain pending with the U.S. FDA. Myovant also is conducting a Phase 3 study to evaluate the prevention of pregnancy in women with uterine fibroids or endometriosis. Myovant also is developing MVT-602, an investigational oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Pharma Co., Ltd., is Myovant’s majority shareholder. For more information, please visit www.myovant.com. Follow @Myovant  on Twitter and LinkedIn

SOURCE: Myovant Sciences

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