Myovant Sciences Announces European Commission Approval of ORGOVYX® (relugolix) for the Treatment of Advanced Hormone-Responsive Prostate Cancer
- ORGOVYX®is thefirstandonlyoralandrogendeprivationtherapyforAdvanced hormone-sensitive prostate cancerinEurope
- Myovant expects to find a European commercialization partner ahead of planned launches
BASEL, Switzerland, April 29, 2022 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV) today announced that the European Commission (EC) has approved the Marketing Authorization Application for ORGOVYX® (relugolix, 120 mg) for the treatment of adult patients with advanced hormone-responsive prostate cancer. The approval applies to the 27 member states of the European Union as well as Iceland, Norway and Liechtenstein.
“Now, for the first time, patients in Europe have the ability to rapidly reduce testosterone without a hormone surge in a convenient oral form,” said Juan Camilo Arjona Ferreira, Medical Director of Myovant Sciences, Inc. “This approval provides a valuable new treatment option for men with advanced hormone-responsive prostate cancer in Europe and has the potential to change the standard of care over time.
“We have made significant progress in finding a commercial partner to commercialize ORGOVYX® in Europe. We have received interest from multiple parties and anticipate an announcement in the coming weeks ahead of planned launches in European markets,” said David Marek, President and CEO of Myovant Sciences, Inc.
This approval is based on data from the Phase 3 HERO study, a multinational, randomized, open-label, parallel-group clinical study designed to evaluate the safety and efficacy of relugolix. The study compared relugolix with leuprolide in more than 1,000 men with advanced androgen-responsive prostate cancer who required at least one year of continuous androgen deprivation therapy. ORGOVYX® received US Food and Drug Administration (FDA) approval for the treatment of adult patients with advanced prostate cancer in December 2020.
In the HERO study, ORGOVYX® achieved the primary endpoint and achieved sustained testosterone suppression to castration levels (® also achieved several key secondary endpoints compared to leuprolide acetate, including suppression of testosterone levels to castrate at day 4 and day 15 (56% vs 0% and 99% vs 12%, respectively ) and profound testosterone suppression (® were hot flushes, musculoskeletal pain, fatigue, constipation, and mild to moderate diarrhea. HERO data was previously presented in an oral presentation at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program, with concurrent publication in The New England Journal of Medicine.
About prostate cancer
Prostate cancer is one of the leading causes of death in the European Union, with approximately 65,200 men dying from the disease in 2016. The standardized mortality rate for prostate cancer was 38 deaths per 100 000 male inhabitants according to Eurostat.
Prostate cancer is considered advanced when it has spread or comes back after initial treatment and may include biochemical recurrence (increase in prostate specific antigen in the absence of metastatic disease on imaging) , locally advanced disease or metastatic disease. First-line medical treatment for advanced prostate cancer usually involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castration levels (
About ORGOVYX® (relugolix)
ORGOVYX® (relugolix, 120 mg) is indicated in Europe for the treatment of adult patients with advanced hormone-responsive prostate cancer. As a GnRH antagonist, ORGOVYX® blocks the GnRH receptor and reduces the production of testicular testosterone, a hormone known to stimulate prostate cancer growth.
About Myovant Sciences
Myovant Sciences is a healthcare company focused on redefining care through differentiated solutions in areas of high unmet need within women’s health and hormone-sensitive oncology. Founded in 2016, Myovant has completed five successful Phase 3 clinical trials in oncology and women’s health, leading to two U.S. Food and Drug Administration (FDA) regulatory approvals for men with cancer advanced prostate cancer and women with heavy menstrual bleeding associated with uterine fibroids, respectively. The company has also received regulatory approvals from the European Commission (EC) for women with symptomatic uterine fibroids and for men with advanced hormone-responsive prostate cancer. The company has an additional new drug application for pain associated with endometriosis pending with the US FDA. Myovant is also conducting a phase 3 study to assess pregnancy prevention in women with uterine fibroids or endometriosis. Myovant is also developing MVT-602, an investigational kisspeptin-1 oligopeptide receptor agonist, which has completed a Phase 2a study in female infertility in assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Pharma Co., Ltd., is the majority shareholder of Myovant. For more information, visit www.myovant.com. Follow @Myovant on Twitter and LinkedIn.
Myovant Sciences forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this press release, forward-looking statements include, but are not limited to, all statements reflecting Myovant Sciences’ expectations, including including: statements regarding Myovant’s aspiration to redefine care through differentiated solutions in areas of high unmet need within women’s health and hormone-sensitive oncology; expectations regarding the potential commercialization and launch of ORGOVYX® for adult patients with advanced hormone-sensitive prostate cancer in Europe; Myovant’s expectations regarding partnership opportunities with multiple interested parties for the European commercialization of relugolix in advanced hormone-responsive prostate cancer, including the timing of any potential partner agreement between now and the planned launch of ORGOVYX® in European markets; and Myovant’s expectations regarding the potential benefits of ORGOVYX® and its potential to become the new standard of care in advanced hormone-sensitive prostate cancer.
For a more in-depth discussion of factors that could materially affect Myovant Sciences’ future operations and prospects, or that could cause actual results to differ materially from expectations, see the risks and uncertainties listed in Myovant Sciences’ filings with the United States Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in Myovant Sciences’ Quarterly Report on Form 10-Q filed on January 26, 2022, as these risk factors are subject to change, supplemented or replaced from time to time. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for the management of Myovant Sciences to predict all risk factors, nor can Myovant Sciences assess the impact of all factors on its business. or the extent to which any factor, or combination of factors, could cause actual results to differ materially from those contained in the forward-looking statements. You should not place undue reliance on the forward-looking statements contained in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update such forward-looking statements to reflect events or circumstances after the date of such statements.
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