Approval for Orgovyx for the treatment of advanced hormone-sensitive prostate cancer
Myovant Sciences 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.”
This approval was supported by data from the Phase III 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 FDA approval for the treatment of adult patients with advanced prostate cancer in December 2020.
Related news and insights
The FDA has approved crizotinib (Xalkori) for the treatment of unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT) in adults and children over 1 year of age.
Bayer announced the FDA has approved a supplemental New Drug Application (sNDA) for the oral androgen receptor inhibitor (ARi) Nubeqa (darolutamide) with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).
Myovant Sciences and Pfizer Inc. announced that the FDA)has approved Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months.