Hukumar Abinci da Magunguna ta ba da izini nirogacestat (OGSIVEO, SpringWorks Therapeutics, Inc.) akan Nuwamba 27, 2023, don manya marasa lafiya da ciwace-ciwacen ciwace-ciwacen daji suna buƙatar magani na tsari. Wannan ita ce farkon da aka ba da izini don ciwan desmoid.
Wani bincike mai suna DeFi (NCT03785964) ya duba yadda yake aiki sosai. Ya kasance na kasa da kasa, multicenter, bazuwar (1: 1), makafi biyu, gwaji mai sarrafa wuribo tare da marasa lafiya 142 waɗanda ke da ciwace-ciwacen daji waɗanda ke daɗa muni kuma ba za a iya bi da su tare da tiyata ba. Marasa lafiya sun cancanci idan ƙwayar desmoid ta ci gaba a cikin watanni 12 bayan an gwada su. An ba da izini ga mahalarta don ɗaukar 150 MG na nirogacestat ko placebo a baki sau biyu a rana har sai rashin lafiya ya ci gaba ko rashin haƙuri.
Rayuwa ba tare da ci gaba ba (PFS) wanda RECIST v1.1 ya ƙididdige ta hanyar nazari na tsakiya mai zaman kansa mai zaman kansa ko ci gaban asibiti wanda mai binciken ya tantance kuma ya sake duba kansa ita ce babbar hanyar auna yadda aikin ya yi aiki. Ba a ƙayyade rayuwa ba tare da ci gaba ba (PFS) a cikin ƙungiyar nirogacestat (95% CI: ba a ƙayyade ba) kuma ya kasance watanni 15.1 (95% CI: 8.4, ba a ƙayyade) a cikin ƙungiyar placebo ba. Matsakaicin haɗari (HR) shine 0.29 (95% CI: 0.15, 0.55) tare da p-darajar ƙasa da 0.001. Binciken farko na tsira ba tare da ci gaba ba (PFS) ta amfani da ci gaba na rediyo kawai ya nuna haɗarin haɗari na 0.31 (95% CI: 0.16, 0.62).
Haƙiƙanin amsawa (ORR) shine ƙarin ma'auni na tasiri. Maƙasudin Amsa Maƙasudin (ORR) shine 41% (95% CI: 29.8, 53.8) don mahalarta a cikin ƙungiyar nirogacestat da 8% (95% CI: 3.1, 17.3) ga waɗanda ke cikin rukunin placebo (p-darajar = <0.001) ). Haɓakawa a cikin marasa lafiya da aka ba da rahoton mummunan zafi daga farkon binciken, wanda ya fi son ƙungiyar nirogacestat, ya kara tabbatar da sakamakon tasiri.
Abubuwan da ba su da kyau sun haɗa da zawo, guba na ovarian, rash, tashin zuciya, gajiya, stomatitis, ciwon kai, rashin jin daɗi na ciki, tari, alopecia, kamuwa da cututtuka na numfashi na sama, da dyspnea.
Matsakaicin nirogacestat da aka ba da shawarar shine MG 150 ana sha da baki sau biyu a rana, tare da ko ba tare da abinci ba, har sai rashin lafiya ya ci gaba ko kuma akwai guba da ba za a yarda da ita ba. Kowane kashi na 150 MG ya ƙunshi kwayoyi 50 MG guda uku.
Cancer
Lutetium Lu 177 dotatate an amince da shi ta USFDA don marasa lafiya na yara masu shekaru 12 da haihuwa tare da GEP-NETS
Lutetium Lu 177 dotatate, magani mai ban sha'awa, kwanan nan ya sami izini daga Hukumar Abinci da Magunguna ta Amurka (FDA) ga marasa lafiya na yara, wanda ke nuna gagarumin ci gaba a cikin ilimin cututtukan cututtukan yara. Wannan amincewar tana wakiltar alamar bege ga yara masu fama da ciwace-ciwacen ƙwayoyin cuta na neuroendocrine (NETs), nau'in ciwon daji da ba kasafai ba amma ƙalubale wanda galibi ke tabbatar da juriya ga hanyoyin warkewa na al'ada.
Alysha Mendossa
Bari 11, 2024
