Nov 2023: I-Food and Drug Administration (FDA) igunyaze i-Ivosidenib (Tibsovo, i-Servier Pharmaceuticals LLC) ngoNovemba 2023 yokwelashwa kweziguli ezikhulile ezine-myelodysplastic syndromes (MDS) ebuyela emuva noma e-refractory myelodysplastic syndromes (MDS) ezinokushintshashintsha kwe-isocitrate dehydrogenase-1 (IDH1) okungenzeka Ukuhlolwa okugunyazwe yi-FDA.
I-FDA iphinde yagunyaza i-Abbott RealTime IDH1 Assay njengethuluzi lokuxilonga elingumngane lokukhetha iziguli ukuthi zithole i-ivosidenib.
Ukugunyazwa bekusekelwe ku-AG120-C-001 (NCT02074839), uhlolo lwengalo eyodwa, ilebula evulekile, izikhungo eziningi ezineziguli zabantu abadala eziyi-18 ezazibuyelwe kabusha noma i-MDS ephikisayo kanye nokushintshashintsha kwe-IDH1. Ukuguqulwa kwe-IDH1 kukhonjwe ngokusetshenziswa kokuhlolwa kwendawo noma okumaphakathi egazini le-peripheral noma umnkantsha wamathambo, futhi kwaqinisekiswa ngemva kwalokho ngokuhlaziywa kokubheka emuva kusetshenziswa i-Abbott RealTime IDH1 Assay.
I-inosidenib yomlomo yayisetshenziswa ngesilinganiso sokuqala se-500 mg ngosuku ngendlela eqhubekayo izinsuku ezingu-28, noma kuze kube yilapho ukufakelwa kwe-hematopoietic stem cell, ukuqhubeka kwesifo, noma ubuthi obungamukeleki. Isilinganiso sobude besikhathi sokwelashwa kwakuyizinyanga eziyi-9.3. Ngemva kokuthola i-ivosidenib, ukufakelwa kwe-stem cell kwenziwa esigulini esisodwa.
Izinga lokusuka ekudingeni ukumpontshelwa igazi uye ekungalidingi, izinga lokukhululwa okuphelele (CR) noma ukukhululwa okuyingxenye (PR) (impendulo yeQembu Lokusebenza Lamazwe Ngamazwe ka-2006 ye-MDS), kanye nobude be-CR+PR basetshenziselwe ukwahlulela ukuthi kuhle kangakanani. ukwelashwa kwasebenza. Impendulo ngayinye ephawuliwe yakha i-CR. I-389.9% yayiyizinga le-CR (95% CI: 17.3, 64.3%). Isikhathi esimaphakathi sokuya ku-CR kwakuyizinyanga eziyi-1.9, nebanga lezinyanga ezi-1.0 kuye kweziyi-5.6. Kodwa-ke, ubude besikhathi obumaphakathi be-CR abukwazanga ukulinganiselwa, kusukela ezinyangeni ezingu-1.9 kuya kwezingu-80.8+. Ezigulini eziyisishiyagalolunye ekuqaleni ebezithembele kumangqamuzana egazi abomvu (RBC) kanye nokumpontshelwa kwe-platelet, eziyisithupha (67%) zithole ukuzimela ku-RBC kanye nokumpontshelwa kwe-platelet phakathi kwanoma yisiphi isikhathi sezinsuku ezingama-56 kulandela isisekelo. Iziguli eziyisikhombisa kweziyisishiyagalolunye ezazingampontshelwa ekuqaleni, okuhlanganisa nokumpontshelwa kwe-platelet kanye ne-RBC, zahlala zingampontshelwa noma yisiphi isikhathi sezinsuku ezingama-56 ngemva kwesikhathi sokuqala (amaphesenti angama-78).
Uma kuqhathaniswa nokusabela okubi okuvame kakhulu okubonwa nge-ivosidenib monotherapy ye-AML, lokhu kwaba ukusabela okubi okuvame kakhulu. Ngaphandle kokuqunjelwa, isicanucanu, i-arthralgia, ukukhathala, ukukhwehlela kanye ne-myalgia), lezi zimpawu zihlanganisa nokuqubuka kanye ne-arthralgia. I-QTc ingase inwetshwe yi-Tibsovo.
Isexwayiso Esinebhokisi sifakiwe olwazini olunqumayo lokuxwayisa iziguli kanye nabasebenzi bezempilo mayelana nobungozi obunamandla bokuhlukanisa besifo.
Buka imininingwane egcwele ye-Tibsovo.
