Maraykanka FDA ayaa ogolaaday gilteritinib ( Xospata ) daaweynta bukaanka qaangaarka ah ee qaba FLT3 dib-u-soo-kabashada togan ama dib-u-soo-kabashada myoid leukemia ba'an ( AML ).
Marka lagu isticmaalo gilteritinib, waxay sidoo kale abaal-marinaysaa tignoolajiyada baaritaanka hidde-raaca saaxiibka. Habka ogaanshaha beddelka ee LeukoStrat CDx FLT3 ee ay samaysay Invivoscribe Technologies, Inc. ayaa loo isticmaalaa in lagu ogaado isbeddellada FLT3 ee bukaannada AML.
"Qiyaastii 25% -30% bukaannada AML ee leh FLT3 hiddo-wadaha is-beddelay," FDA Xarunta Maamulka Dawooyinka ee FDA ee Agaasimaha Wax soo saarka Oncology iyo Hematology iyo Oncology Center Richard Pazdur, MD, iyo Cilmi-baarista, ayaa lagu yiri bayaan. "Isbeddelladani waxay si gaar ah ula xiriiraan qallafsanaanta kansarka iyo khatarta sare ee soo noqoshada. "
Pazdur wuxuu intaas ku daray in gilteritinib uu yahay dawadii ugu horaysay ee la ansixiyay ee loo isticmaalo monotherapy ee bukaanka AML.
FLT3 waa hiddo-wadaha inta badan la beddelo ee lagu aqoonsaday AML, iyo FLT3 tandem gudaha ku celcelinta isbeddellada waxay la xidhiidhaan heerarka soo noqoshada sare, cafiska gaaban, iyo natiijooyinka badbaadada liidata. Gilteritinib waa FLT3 tyrosine kinase inhibitor ah oo si heer sare ah loo xushay kaas oo lagu muujiyay inuu leeyahay waxqabad ka dhan ah isbeddellada FLT3 ITD, wuxuuna sidoo kale xannibaa isbeddellada FLT3 D835 kaas oo keeni kara caabbinta caafimaad ee kuwa kale ee FLT3.
Bukaannada 252 ee isdiiwaangeliyey wajiga hore ee tijaabada 1/2 waxay muujiyeen in 49% bukaanada qaba dib udhaca ama diidmada AML iyo isbeddelada FLT3 ay kajawaabeen gilteritinib. Badbaadada dhexe ee kaqeybgalayaashani waxay ka badneyd 7 bilood. Kaliya 12% bukaanada aan lahayn isbeddelada FLT3 waxay ka jawaabeen gilteritinib, iyagoo bixiyay caddeyn muujineysa in loo isticmaali karo kahortaga xulashada mutant FLT3
Ansixinta waxay ku saleysneyd xogta ka soo baxday daraasadda ADMIRAL, tijaabin weji 3 ah oo 138 bukaanno waaweyn ah oo qaba FLT3- AML ay dib-ugu-soo-noqosho / diidmo AML ay heleen 120 mg oo ah gefitinib afka ah maalin kasta. Kooxdan, 21% bukaannadu waxay ku guuleysteen dhammaystir dhammaystiran ama dhammaystir dhammaystiran qayb ahaan soo-kabashada dhiig-baxa. Tijaabada ADMIRAL lafteedu wali way socotaa, jawaab faahfaahsan iyo guud ahaan xogta badbaadada ayaa la filayaa in la daabaco sanadka soo socda.
https://www.medscape.com/viewarticle/905713
