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Recently, Myovant Sciences announced that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for relugolix for the treatment of advanced prostate cancer and will begin a formal review process.
Relugolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist that inhibits the production of testosterone in the testes, a hormone that stimulates the growth of prostate cancer cells.
One of the conventional treatment options for advanced prostate cancer is androgen deprivation therapy (ADT), which uses drugs to reduce the level of hormones that help prostate cancer cells grow.
In December 2020, relugolix was approved by the US FDA for the treatment of adult patients with advanced prostate cancer.
According to the terms of Myovant and Pfizer's cooperative development and commercialization of relugolix, Pfizer has the right to commercialize relugolix in the field of oncology outside the United States and Canada (excluding certain Asian countries).
Relugolix's regulatory application for the treatment of advanced prostate cancer is based on the positive results of the Phase III HERO study.
The results showed that relugolix reached the primary efficacy endpoint: within 48 weeks of treatment, 96.
relugolix was developed by Takeda, and Myovant Sciences (a company formed by Roivant and Takeda) obtained the exclusive global license in June 2016 except Japan and other Asian countries.
In the United States, prostate cancer is the second leading cancer in men and the second leading cause of death from cancer in men.
Note: The original text has been deleted
Original Source: Myovant Sciences Announces European Medicines Agency Validation of Marketing Authorization application for Relugolix for the Treatment of Advanced Prostate Cancer