The US Food and Drug Administration (FDA) has approved Myovant’s once-daily pill Orgovyx for prostate cancer.
Orgovyx (relugolix), which will become available for advanced prostate cancer patients in the US, offers a new option that enables at-home administration.
This is a particularly attractive option for patients looking to avoid travelling for in-person injections, especially in light of the ongoing COVID-19 pandemic.
“The COVID-19 pandemic has heightened the importance of oral treatments as men with prostate cancer continue to experience difficulties and risks travelling to receive injections,” said Neal Shore, medical director of the Carolina Urologic Research Center and HERO programme steering committee member.
The phase 3 HERO study enrolled 934 men with advanced prostate cancer, assigning them in a 2:1 ratio to receive either Orgovyx or depot injections of Lupron (leuprolide) – a standard-of-care treatment for prostate cancer patients.
In this study, Orgovyx achieved sustained testosterone suppression to castrate levels in 96.7% of patients from week five to week 48, in comparison to 88.8% for those receiving leuprolide acetate injections.
Secondary endpoints from the study showed that relugolix was better than Lupron at suppressing testosterone quickly (four to 15 days after dosing started), suppressing prostate-specific antigen PSA at day 15 and reducing levels of follicle-stimulating hormone (FSH), which can drive tumour growth in prostate cancer.
Orgovyx is the first oral gonadotropin-releasing hormone (GnRH) receptor antagonist to receive FDA approval for the treatment of advanced prostate cancer.
It is designed to block the GnRH receptor, which in return reduces the production of testicular testosterone, a hormone known to stimulate the growth of prostate cancer.
“With the approval of Orgovyx, men with advanced prostate cancer now have a new oral treatment option that has demonstrated robust efficacy and safety, all with one pill taken once a day,” said Lynn Seely, chief executive officer of Myovant Sciences.
“We have successfully built our commercial capabilities to bring this newly approved treatment to the urologists and oncologists who care for men with advanced prostate cancer, with the goal of establishing Orgovyx as the new standard of care.
“We are incredibly grateful to the men and investigators who participated in the HERO study and to the FDA for expediting the review and approval of Orgovyx through its priority review pathway,” she added.