I-US FDA ivumile umagasine ( Xospata ) ekwelashweni weziguli zabantu abadala abane I-FLT3 ukubuyela emuva kokuhle okuguqukayo noma i-reflexory acute myeloid leukemia ( I-AML ).
Uma isetshenziswa ne-gilteritinib, iphinda iklomelise ubuchwepheshe bokuhlola izakhi zofuzo obuhambisanayo. Indlela yokuthola ukuguqulwa kwe-LeukoStrat CDx FLT3 eyakhiwe yi-Invivoscribe Technologies, Inc. isetshenziselwa ukuthola ukuguqulwa kwe-FLT3 ezigulini ze-AML.
"Cishe u-25% -30% weziguli ze-AML ezine-FLT3 ziye zashintsha izakhi zofuzo," i-FDA Drug Administration Centre yomqondisi we-FDA we-Oncology and Hematology kanye ne-Oncology Center ongumqondisi obambile womkhiqizo uRichard Pazdur, MD, ne-Research, kusho isitatimende. ”Lokhu kuguquka kuhlotshaniswa ikakhulukazi nolaka lomdlavuza kanye nengozi enkulu yokuphindeka. "
UPazdur wengeze ngokuthi i-gilteritinib iyisidakamizwa sokuqala esivunyelwe ukuthi sisetshenziswe njenge-monotherapy ezigulini ze-AML.
I-FLT3 iwufuzo oluvame ukushintshwa olukhonjwe ku-AML, futhi ukuguqulwa kwe-FLT3 kwangaphakathi kwe-tandem kuhlotshaniswa namazinga aphezulu okuphinda aqubuke, ukukhishwa okufushane, kanye nemiphumela engemihle yokusinda. I-Gilteritinib iyi-FLT3 tyrosine kinase inhibitor ekhetha kakhulu eboniswe inomsebenzi omelene nokuguqulwa kwe-FLT3 ITD, futhi ivimbela ukuguqulwa kwe-FLT3 D835 okunganikeza ukumelana nomtholampilo kwamanye ama-FLT3 inhibitors.
Iziguli ezingama-252 ezibhalise esigabeni sokuqala sesivivinyo se-1/2 zikhombise ukuthi iziguli ezingama-49% ezinokuphinda zibuyele emuva noma ziphikise ukuguqulwa kwe-AML ne-FLT3 ziphendule i-gilteritinib. Ukusinda okuphakathi kwalaba bahlanganyeli bekungaphezu kwezinyanga eziyi-7. Kuphela yi-12% yeziguli ezingenazo izinguquko ze-FLT3 eziphendule ku-gilteritinib, zinikeza ubufakazi bokuthi ingasetshenziswa njenge-inhibitor ekhethiwe ye-mutant FLT3.
Ukuvunyelwa kwakususelwa kudatha evela ocwaningweni lwe-ADMIRAL, isilingo sesigaba 3 esingahleliwe lapho iziguli zabantu abadala eziyi-138 ezine-FLT3- ezibuyisele emuva / eziphikisayo i-AML zathola i-120 mg ye-oral gefitinib nsuku zonke. Kuleli qembu, iziguli ezingama-21% zithole ukuxolelwa okuphelele noma ukuthethelelwa okuphelele ngokululama ngokwengxenye kwe-hematological. Isivivinyo se-ADMIRAL uqobo lusaqhubeka, futhi impendulo eningiliziwe kanye nemininingwane yokusinda kulindeleke ukuthi ishicilelwe ngonyaka ozayo.
https://www.medscape.com/viewarticle/905713
