August 2021: Prima gonadotropinum hormonum solvens (GnRH) receptor antagonista, relugolix (ORGOVYX, Scientiarum Myovantarum, Inc.), a Cibus et medicamentis administrationis die 18 Decembris 2020 probatus est, adultis aegris cum cancro metastatico prostatae.
HERO (NCT03085095), a randomised, open label trial in males requiring at least one year of androgen deprivation therapy for prostate cancer recurrence after radiotherapy or surgery or newly diagnosed castration-sensitive advanced prostate cancer, was used to assess efficacy. Relugolix 360 mg oral loading dosage on the first day, followed by daily oral doses of 120 mg, or leuprolide acetate 22.5 mg injection subcutaneously every 3 months for 48 weeks were given to patients (N=934).
Clavis efficaciae finis mensurae castrationis medicae erat, quae definita est ut serum testosteronum assequendum et conservandum supprimere ad gradus castrandos (50 ng/dL) per diem 29 curationis et conservationem in proximis 48 septimanis. In relugolix bracchio, castratio medicinae facta est 96.7 centesimas (95 percent CI: 94.9 percent, 97.9 centesimas).
Calidus rubor, dolor musculoskeletalis, lassitudo, diarrhoea, et constipatio partium effectorum (decem cento) in patientibus relugolix in HERO sumptis frequentissimi fuerunt. Glucosum, triglycerides, alaninae aminotransferase auctae, et aminotransferase aspartatis fuerunt abnormitates laboratorium frequentissimae (15%). Etiam hemoglobina minora inventa sunt.
Inprimitur dosis 360 mg prima die, sequitur dosis oralis quotidiana 120 mg, eodem fere tempore quovis die, cum vel sine prandio.
Reference: https://www.fda.gov/
details reprehendo hic.
