Juun 2022: Ivosidenib (Tibsovo, Server Pharmaceuticals LLC) Marka lagu daro azacitidine waxaa u ansixiyay Maamulka Cuntada iyo Dawooyinka ee dhawaan la helay cudurka leukemia ba'an ee myeloid leukemia (AML) ee dadka qaangaarka ah 75 sano ama ka weyn oo leh isbeddel IDH1 u nugul, sida lagu ogaaday baaritaanka FDA-ansixisay, ama kuwa leh cudurada ka hortagga degdega ah daweynta kiimoterabiga induction.
FDA waxay ogolaatay iyada oo ku saleysan natiijooyinka randommis, multicenter, double-indhole, daraasad la xakameeyey placebo (AG120-C-009, NCT03173248) kaas oo diiwaan gashaday 146 bukaan oo qaba AML cusub oo leh isbeddel IDH1 oo ku qanacsan ugu yaraan mid ka mid ah shuruudaha soo socda: da'da 75 sano ama ka weyn, heerka waxqabadka ECG 2, xanuun wadnaha ama sambabada oo weyn, naafanimada beerka leh bilirubin> 1.5 jeer xadka sare ee caadiga ah, creatinine nadiifinta 45 mL/min, ama cudurada kale ee Maalmaha 1-28, bukaanada ayaa la kala soocay 1: 1 si loo helo ivosidenib 500 mg maalin kasta (N=72) ama placebo ku habboon hal mar maalintii (N=74) oo lagu daray azacitidine 75 mg / m2 / maalin maalmaha 1-7 ama Maalmaha 1-5 iyo 8 -9 wareeg kasta oo 28-maalmood ah ilaa uu cudurku ka sii socdo, sunta aan la aqbali karin, ama unugyada unugyada tarma ee hematopoietic ilaa uu cudurku ka sii socdo, suntan aan la aqbali karin, ama tallaalka unugyada tarma ee hematopoietic
Hagaajinta badbaadada xorta ah ee dhacdada (EFS), badbaadada guud (OS), iyo heerka iyo muddada cafiska buuxa ayaa loo isticmaalay si loo go'aamiyo waxtarka (CR). Muddada u dhaxaysa kala soocida ilaa guul darada daawaynta, soo noqoshada cafiska, ama dhimashada sabab kasta, mid kasta oo soo hormaray, waxa loo yaqaan EFS. Ku guuldareysiga in lagu gaaro CR gudaha 24 usbuuc ayaa loo tixgaliyay daaweyn guul darro ah. EFS waxay ku dhacday 65 boqolkiiba ivosidenib iyo bukaanada azacitidine iyo 84 boqolkiiba placebo iyo bukaanada azacitidine (HR 0.35; 95 boqolkiiba CI: 0.17, 0.72, p=0.0038). Dhexdhexaadinta OS ee ivosidenib iyo cududda azacitidine waxay ahayd 24.0 bilood (95 boqolkiiba CI: 11.3, 34.1), halka placebo iyo gacanta azacitidine ay ahayd 7.9 bilood (95 boqolkiiba CI: 4.1, 11.3) (HR 0.44; 95 boqolkiiba CI: 0.27) 0.73; p=0.0010). Heerka CR ee ivosidenib iyo cududda azacitidine waxay ahayd 47 boqolkiiba (95 boqolkiiba CI: 35 boqolkiiba, 59 boqolkiiba) iyo 15 boqolkiiba (95 boqolkiiba CI: 8 boqolkiiba, 25 boqolkiiba) ee placebo iyo gacanta azacitidine. Muddada dhexdhexaadka ah ee CR ee ivosidenib iyo cududda azacitidine ma ahayn mid la qiyaasi karo (NE) (95 boqolkiiba kalsoonida: 13.0, NE) iyo 11.2 bilood (95 boqolkiiba kalsoonida kalsoonida: 3.2, NE) ee placebo iyo cududda azacitidine.
Shuban, daal, edoema, lallabbo, matag, rabitaanka cuntada oo yaraada, leukocytosis, arthralgia, dyspnea, calool xanuun, xuubka xuubka, finan, electrocardiogram QT dheer, kala duwanaanshaha syndrome, iyo myalgia ayaa ahaa falcelinta ugu badan ee xun ee ivosidenib marka lagu daro azacitidine ama sida monotherapy. (25 boqolkiiba tijaabo kasta). Digniin Sanduuqan oo ku saabsan tilmaamaha qorista ayaa uga digaya xirfadlayaasha daryeelka caafimaadka iyo bukaannada suurtagalnimada cudurka kala-duwanaanta, kaas oo noqon kara dilaa ama nafta halis gelin kara.
Ivosidenib waxaa lagu qoraa qiyaasta 500 mg hal mar maalintii, cunto la'aan ama la'aanteed, ilaa uu cudurku ka sii socdo ama sunta aan la aqbali karin. Maalmaha 1-7 (ama maalmaha 1-5 iyo 8-9) ee wareeg kasta oo 28-maalmood ah, billow maamulida ivosidenib iyadoo lala kaashanayo azacitidine 75 mg/m2 subcutaneously ama xididka hal mar maalintii. Daaweynta waxaa loo soo jeediyay ugu yaraan 6 bilood bukaannada aan lahayn horumar jirro ama sun la'aan si loo siiyo waqti jawaab-celinta bukaan-socodka.
U fiirso macluumaadka dhamaystiran ee Tibsovo
