Jakavi/Jakafi Ua Tau Zoo hauv Kev Kho Mob Steroid Refractory Chronic Graft-versus-host Disease (GvHD)!-1/2

Novartis thiab nws tus khub Incyte tsis ntev los no tau tshaj tawm qhov kev tshuaj xyuas ntawm cov txiaj ntsig zoo ntawm theem tseem ceeb 3 REACH3 kev kawm (NCT03112603) ntawm qhov ncauj JAK1/2 inhibitor Jakavi/Jakafi (ruxolitinib) hauv kev kho mob steroid-refractory mob hnyav-tiv thaiv-tus kab mob tus kab mob (GvHD) Nws tau tshaj tawm hauv cov ntawv xov xwm kho mob thoob ntiaj teb sab saum toj" New England Journal of Medicine" (NEJM), nrog lub ntsiab lus ntawm kab lus: Ruxolitinib rau Glucocorticoid-Refractory Chronic Graft-versus-Host Disease.

REACH3 tau koom ua ke txhawb nqa los ntawm Novartis thiab Incyte. Nov yog qhov kev xaiv, qhib-daim ntawv lo, ntau qhov chaw nruab nrab theem 3 txoj kev kawm rau cov menyuam yaus uas tau tsim cov tshuaj tiv thaiv kab mob los yog tshuaj tiv thaiv kab mob sib kis-tiv thaiv tus kab mob (GvHD) tom qab tau txais tag nrho cov qia cell hloov chaw. (≥12 xyoos) thiab cov neeg mob laus. Cov ntaub ntawv qhia tias piv nrog kev kho tau zoo tshaj plaws (BAT), ruxolitinib txhim kho qhov kev kwv yees ntawm cov neeg mob nrog cov tshuaj steroid-refractory/vam khom GvHD, suav nrog kev txhim kho kev ua tsis tau zoo nyob tsis muaj sia (FFS) thiab cov tsos mob ntawm tus neeg mob. Kev tshuaj xyuas pawg tshiab tau pom tias nyob rau 24 lub lim tiam ntawm kev kho mob, ruxolitinib pom qhov ua tau zoo dua qub (ORR) hauv txhua pawg pawg loj (suav nrog kev koom tes hauv lub hauv paus) piv nrog BAT.

Chronic GvHD yog kab mob uas txaus ntshai rau lub neej. Nws yog ib qho teeb meem mus sij hawm ntev ntawm kev hloov pauv qia cell uas tuaj yeem cuam tshuam rau ntau yam kabmob. Kwv yees li ib nrab ntawm cov neeg mob uas tau txais thawj kab tshuaj kho mob yuav tsim kho cov tshuaj tsis haum xeeb/kev vam khom. Nws tsim nyog hais tias ruxolitinib yog thawj cov tshuaj los qhia kev ua tau zoo hauv kev kho mob ntawm cov tshuaj steroid-refractory/nyob ntawm tus mob GvHD nyob rau qhov loj ntawm kev sim tshuaj kho mob loj.

ruxolitinibyog tus pib ua JAK1/JAK2 inhibitor, muag los ntawm Incyte hauv Tebchaws Meskas (lub npe lag luam Jakafi), thiab Novartis tau tso cai muag nws sab nraum Tebchaws Meskas (lub npe lag luam Jakavi). Raws li cov txiaj ntsig ntawm REACH3 txoj kev tshawb fawb, Incyte tau xa Daim Ntawv Thov Tshuaj Ntxiv (sNDA) los ntawm Jakafi mus rau Asmeskas FDA rau kev kho menyuam yaus (≥12 xyoo) thiab cov neeg laus nrog steroid-refractory ntev GvHD. Tam sim no, qhov sNDA no tseem tab tom tshuaj xyuas FDA, thiab lub hom phiaj ua hnub kawg yog Cuaj Hlis 22, 2021. Rau Novartis, kev tswj hwm xa mus rau Jakavi rau kev kho mob hnyav thiab mob ntev GvHD sab nraum Tebchaws Meskas tab tom ua tiav.

Dr. Robert Zeiser, Department of Hematology, Oncology and Stem Cell Transplantation, University Tsev Kho Mob ntawm Freiburg, Lub Tebchaws Yelemees, tau hais tias: "Cov neeg mob uas muaj tus mob GVHD tau mob hnyav thiab ua rau muaj kev phom sij rau lub neej nyob rau hauv lub cev sib txawv ntawm lub cev, uas ua rau tus kabmob nyuaj rau kho thiab ua rau kom muaj kev phom sij tsis zoo. Los ntawm cov txiaj ntsig tshiab no ntawm REACH3 txoj kev tshawb fawb, peb tuaj yeem pom meej meej pom cov txiaj ntsig kho mob ntawmruxolitinibraws li muaj peev xwm ua tus txheej txheem tshiab ntawm kev saib xyuas hauv cov neeg mob uas muaj GvHD ntev uas tsis teb rau thawj kab steroids."