Juni 2022: Ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) kuhlanganiswe ne-azacitidine kuvunywe i-Food and Drug Administration ye-acute myeloid leukemia (AML) esanda kutholwa kubantu abadala abaneminyaka engu-75 noma ngaphezulu abanoguquko olunamandla lwe-IDH1, njengoba kutholwe ukuhlolwa okugunyazwe yi-FDA, noma abanezifo ezivimbela ukuqina. i-induction chemotherapy.
I-FDA inikeze imvume ngokusekelwe emiphumeleni yocwaningo olulawulwa ngokungahleliwe, olumaphakathi, olungaboni kabili, olulawulwa yi-placebo (AG120-C-009, NCT03173248) olubhalise iziguli eziyi-146 ezine-AML esanda kutholwa ene-IDH1 eguquguqukayo enelise okungenani eyodwa ye Izindlela ezilandelayo: iminyaka yobudala engama-75 noma ngaphezulu, isimo sokusebenza kwe-ECG 2, isifo senhliziyo esibalulekile noma sephaphu, ukukhubazeka kwesibindi nge-bilirubin> izikhathi ezi-1.5 kunomkhawulo ophezulu wesilinganiso esivamile, imvume ye-creatinine engu-45 mL/min, noma ezinye izifo ezihambisanayo Ezinsukwini 1-28, iziguli benziwe ngokungahleliwe 1:1 ukuze bathole ivosidenib 500 mg nsuku zonke (N=72) noma i-placebo ehambisanayo ngomlomo kanye ngosuku (N=74) kuhlanganiswe ne-azacitidine 75 mg/m2/ngosuku ngezinsuku 1-7 noma Izinsuku 1-5 kanye no-8 -9 kumjikelezo ngamunye wezinsuku ezingama-28 kuze kube ukuqhubekela phambili kwesifo, ubuthi obungamukeleki, noma ukufakelwa kwe-hematopoietic stem cell kuze kuqhubeke isifo, ubuthi obungamukeleki, noma ukufakelwa kwe-hematopoietic stem cell
Ukuthuthukiswa kokusinda komcimbi (EFS), ukusinda okuphelele (OS), kanye nezinga nesikhathi sokukhululwa okugcwele kusetshenziswe ukucacisa ukusebenza kahle (CR). Isikhathi esisuka ekwenziweni okungahleliwe kuya ekuhlulekeni kokwelashwa, ukubuyela emuva ekuxolelweni, noma ukufa kunoma yisiphi isizathu, kungakhathaliseki ukuthi iyiphi eyafika kuqala, yayibizwa nge-EFS. Ukwehluleka ukuthola i-CR phakathi kwamaviki angama-24 kuthathwe njengokwehluleka kokwelashwa. I-EFS yenzeke kumaphesenti angu-65 eziguli ze-ivosidenib kanye ne-azacitidine kanye namaphesenti angu-84 eziguli ze-placebo kanye ne-azacitidine (HR 0.35; 95 amaphesenti CI: 0.17, 0.72, p=0.0038). I-OS emaphakathi engalweni ye-ivosidenib kanye ne-azacitidine kwakuyizinyanga ezingu-24.0 (amaphesenti angu-95 CI: 11.3, 34.1), kuyilapho ingalo ye-placebo ne-azacitidine yayiyizinyanga ezingu-7.9 (amaphesenti angu-95 CI: 4.1, 11.3) (HR 0.44; 95 amaphesenti CI: 0.27, 0.73; p=0.0010). Izinga le-CR engalweni ye-ivosidenib kanye ne-azacitidine yayingamaphesenti angu-47 (amaphesenti angu-95 CI: amaphesenti angu-35, amaphesenti angu-59) namaphesenti angu-15 (amaphesenti angu-95 CI: amaphesenti angu-8, amaphesenti angu-25) engalweni ye-placebo kanye ne-azacitidine. Ubude besikhathi obumaphakathi be-CR engalweni ye-ivosidenib kanye ne-azacitidine bebungalinganiselwa (NE) (isikhawu sokuzithemba samaphesenti angama-95: 13.0, NE) kanye nezinyanga eziyi-11.2 (isikhawu sokuzithemba samaphesenti angama-95: 3.2, NE) ku-placebo kanye nengalo ye-azacitidine.
Uhudo, ukukhathala, ukuqunjelwa, isicanucanu, ukuhlanza, ukuncipha kwesifiso sokudla, i-leukocytosis, i-arthralgia, i-dyspnea, ubuhlungu besisu, i-mucositis, ukuqubuka, i-electrocardiogram QT isikhathi eside, ukuhlukaniswa kwe-syndrome, kanye ne-myalgia kwakuyizimo ezimbi ezivame kakhulu ze-ivosidenib ngokuhlangana ne-azacitidine noma njenge-monotherapy. (amaphesenti angama-25 kunoma yisiphi isilingo). Isexwayiso Esinebhokisi emibhalweni echazayo sixwayisa ochwepheshe bezempilo neziguli mayelana nokwenzeka kwesifo sokuhlukanisa, esingabulala noma sibeke ukuphila engozini.
I-Ivosidenib inqunywa umthamo we-500 mg kanye ngosuku, ngokudla noma ngaphandle kokudla, kuze kube yilapho isifo siqhubeka noma ubuthi obungamukeleki. Ngezinsuku ze-1-7 (noma Izinsuku 1-5 kanye ne-8-9) zomjikelezo ngamunye wezinsuku ezingu-28, qala ukuphatha i-ivosidenib ngokuhambisana ne-azacitidine 75 mg / m2 ngaphansi kwesikhumba noma nge-intravenously kanye ngosuku. Ukwelashwa kuphakanyiswa okungenani izinyanga eziyi-6 ezigulini ezingaqhubeki nokugula noma ubuthi obubalulekile ukunikeza isikhathi sokusabela emtholampilo.
Buka imininingwane egcwele ye-Tibsovo
