Amurka FDA ya yarda gilteritinib ( Xospata ) don magani na manya marasa lafiya tare da FLT3 maye gurbi-tabbatacce koma baya ko refractory m myeloid cutar sankarar bargo ( AML ).
Lokacin da aka yi amfani da shi tare da gilteritinib, yana kuma ba da lambar yabo ta abokan hulɗar fasahar gwajin kwayoyin halitta. Hanyar gano maye gurbi na LeukoStrat CDx FLT3 wanda Invivoscribe Technologies, Inc. ya haɓaka ana amfani dashi don gano maye gurbin FLT3 a cikin marasa lafiya na AML.
"Kusan 25% -30% na marasa lafiya na AML tare da FLT3 mutated genes," FDA Drug Administration Center for FDA darektan Oncology da Hematology da Oncology Cibiyar samfurin riko Richard Pazdur , MD, da Bincike, ya ce a cikin wata sanarwa. "Wadannan maye gurbi suna da alaƙa musamman da zafin ciwon daji da kuma haɗarin sake dawowa. "
Pazdur ya kara da cewa gilteritinib shi ne magani na farko da aka amince da shi wanda za a yi amfani da shi azaman maganin jinya a cikin marasa lafiyar AML.
FLT3 ita ce mafi yawan maye gurbin kwayar halitta da aka gano a cikin AML, kuma FLT3 na maimaita maye gurbi na ciki yana da alaƙa da ƙimar koma baya, gajeriyar remissions, da rashin kyakkyawan sakamakon rayuwa. Gilteritinib shine mai zaɓin FLT3 tyrosine kinase mai hanawa wanda aka nuna yana da aiki akan maye gurbin FLT3 ITD, kuma yana hana maye gurbin FLT3 D835 wanda zai iya ba da juriya na asibiti ga sauran masu hana FLT3.
Magunguna na 252 da suka shiga cikin farkon gwajin 1/2 sun nuna cewa 49% na marasa lafiya tare da sake dawowa ko ƙin AML da maye gurbi na FLT3 sun amsa ga gilteritinib. Matsakaicin matsakaiciyar waɗannan mahalarta ya fi watanni 7. Kawai 12% na marasa lafiya ba tare da maye gurbi na FLT3 sun amsa ga gilteritinib, suna ba da shaida cewa ana iya amfani da shi azaman mai hana zaɓin maye gurbi na FLT3.
Amincewar ta dogara ne akan bayanai daga binciken ADMIRAL, gwajin gwagwarmaya ta 3 wanda bazuwarta inda 138 manya marasa lafiya tare da FLT3- tabbataccen koma baya / rashin ƙarfi AML suka karɓi MG 120 na gefitinib na baka kullum. A cikin wannan rukuni, 21% na marasa lafiya sun sami cikakkiyar gafara ko cikakkiyar gafara tare da dawo da cututtukan jini. Gwajin ADMIRAL da kansa yana kan ci gaba, kuma ana sa ran buga cikakken bayani da kuma bayanan rayuwa gaba ɗaya shekara mai zuwa.
https://www.medscape.com/viewarticle/905713
