August 2021: Hormoonkii ugu horreeyay ee gonadotropin-sii-daynta afka ah (GnRH) antagonist, relugolix (ORGOVYX, Myovant Sciences, Inc.), waxaa ansixiyay Maamulka Cuntada iyo Dawooyinka Diseembar 18, 2020, bukaannada qaangaarka ah ee qaba kansarka qanjirka 'metastatic'.
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).
Qiyaasta dhammaadka waxtarka ee muhiimka ah waxay ahayd heerka qallafsanaanta caafimaadka, kaas oo lagu qeexay sidii lagu gaari lahaa loona ilaalin lahaa xakamaynta testosterone ee heerarka castrate (50 ng / dL) maalinta 29 ee daaweynta iyo ilaalinta toddobaadyada 48 ee soo socda. Cududda relugolix, heerka kasbashada caafimaadku wuxuu ahaa 96.7 boqolkiiba (95 boqolkiiba CI: 94.9 boqolkiiba, 97.9 boqolkiiba).
Biyo-bax kulul, muruq xanuun, daal, shuban, iyo calool-istaag ayaa ah waxyeellooyinka ugu badan (boqolkiiba toban) bukaannada qaadanaya relugolix ee HERO. Korodhka gulukooska, triglycerides, alanine aminotransferase, iyo aspartate aminotransferase ayaa ahaa cilladaha shaybaadhka ee ugu badan (15%). Hemoglobin ayaa sidoo kale la ogaaday inuu hooseeyo.
Qiyaasta rarka ee 360 mg maalinta ugu horeysa ayaa la tilmaamayaa, oo ay ku xigto qiyaasta afka maalinlaha ah ee 120 mg qiyaastii isku mar maalin kasta, cunto la'aan ama la'aan.
Tixraac: https://www.fda.gov/
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