I-Food and Drug Administration igunyaze i-nirogacestat (OGSIVEO, SpringWorks Therapeutics, Inc.) ngoNovemba 27, 2023, ezigulini ezikhulile ezinamathumba e-desmoid athuthukayo adinga ukwelashwa okuhlelekile. Lokhu ukwelashwa okugunyaziwe kokuqala kwamathumba e-desmoid.
Ucwaningo olubizwa nge-DeFi (NCT03785964) lubheke ukuthi lusebenze kahle kangakanani. Kwakuwukuhlolwa kwamazwe ngamazwe, okuxubile, okungahleliwe (1:1), okungaboni kabili, okulawulwa yi-placebo neziguli eziyi-142 ezazinamathumba e-desmoid ayesiba mabi kakhulu futhi ayengelapheka ngokuhlinzwa. Iziguli zazifaneleka uma isimila se-desmoid sithuthuke phakathi nezinyanga eziyi-12 ngemva kokuhlolwa. Abahlanganyeli babelwa ngokungahleliwe ukuthi bathathe i-150 mg ye-nirogacestat noma i-placebo ngomlomo kabili ngosuku kuze kube yilapho ukugula kuqhubeka noma ubuthi obungabekezeleleki.
Ukusinda kwe-Progression-free survival (PFS) kubalwe yi-RECIST v1.1 ngokubuyekezwa okuzimele okuphuphuthekile noma ukuqhubeka komtholampilo okuhlolwe umphenyi futhi kwabuyekezwa ngokuzimela kwakuyindlela eyinhloko yokukala ukuthi ukwelashwa kusebenza kahle kangakanani. Ukusinda kwe-median progression-free survival (PFS) akunqunywanga eqenjini le-nirogacestat (95% CI: akunqunywanga) futhi kwakuyizinyanga ezingu-15.1 (95% CI: 8.4, ezinganqunywanga) eqenjini le-placebo. Isilinganiso sengozi (HR) sasingu-0.29 (95% CI: 0.15, 0.55) enenani lika-p elingaphansi kuka-0.001. Uphenyo lokuqala lwe-progression-free survival (PFS) kusetshenziswa ukuqhubekela phambili kwe-radiographic kuphela kwembule isilinganiso sengozi esingu-0.31 (95% CI: 0.16, 0.62).
Inhloso yokusabela rate (ORR) bekuyisilinganiso esengeziwe sokusebenza kahle. I-Objective Response Rate (ORR) yayingu-41% (95% CI: 29.8, 53.8) kubahlanganyeli beqembu le-nirogacestat kanye no-8% (95% CI: 3.1, 17.3) kulabo abaseqenjini le-placebo (p-value=<0.001 ). Ukuthuthukiswa kwezinhlungu ezimbi kakhulu ezibikwe isiguli kusukela ekuqaleni kocwaningo, okwakuthandeka iqembu le-nirogacestat, kuphinde kwaqinisekisa imiphumela yokusebenza kahle.
Imiphumela emibi evamile yayihlanganisa isifo sohudo, ubuthi be-ovarian, ukuqubuka, isicanucanu, ukukhathala, i-stomatitis, ikhanda elibuhlungu, ukungakhululeki kwesisu, ukukhwehlela, i-alopecia, ukutheleleka kwepheshana eliphezulu lokuphefumula kanye ne-dyspnea.
Umthamo ophakanyisiwe we-nirogacestat ngu-150 mg othathwa ngomlomo kabili ngosuku, ngokudla noma ngaphandle kokudla, kuze kube yilapho ukugula kuqhubeka noma kukhona ubuthi obungamukeleki. Umthamo ngamunye we-150 mg unamaphilisi amathathu angama-50 mg.
Cancer
I-Lutetium Lu 177 dotatate igunyazwe yi-USFDA yeziguli zezingane ezineminyaka engu-12 nangaphezulu nge-GEP-NETS
I-Lutetium Lu 177 dotatate, ukwelashwa okuyisimangaliso, isanda kuthola imvume evela kwa-US Food and Drug Administration (FDA) yeziguli zezingane, okumaka ingqopha-mlando ku-oncology yezingane. Lokhu kugunyazwa kumelele ukukhanya kwethemba ezinganeni ezilwa nezimila ze-neuroendocrine (NETs), uhlobo lomdlavuza oluyivelakancane kodwa oluyinselele oluvame ukufakazela ukumelana nemithi evamile.
Alysha Mendossa
Kwangathi 11, 2024
