IU.S. FDA yabvuma gilteritinib ( Xospata ) yekurapa yevakuru varwere vane FLT3 mutation-positive relapse kana refractory acute myeloid leukemia ( AML ).
Kana yakashandiswa ne gilteritinib, inopawo mubairo weanoongorora genetic test tekinoroji. Iyo LeukoStrat CDx FLT3 mutation yekuongorora nzira yakagadzirwa neInvivoscribe Technologies, Inc. inoshandiswa kuona FLT3 kuchinja kwevarwere ve AML.
"Inenge 25% -30% yevarwere veAML vane FLT3 mutated genes," FDA Drug Administration Center yeFDA director weOncology and Hematology and Oncology Center acting director Richard Pazdur, MD, and Research, vakadaro mukutaura. ” Kuchinja uku kunonyanya kuenderana nehutsinye hwegomarara uye njodzi huru yekudzokazve. “
Pazdur akawedzera kuti gilteritinib ndiyo yekutanga mishonga inobvumidzwa kushandiswa se monotherapy muAML varwere vanhu.
FLT3 ndiyo inonyanya kushandurwa gene inowanikwa mu AML, uye FLT3 yemukati tandem inodzokorora shanduko inobatanidzwa nehupamhi hwekudzokazve, kuregererwa kwenguva pfupi, uye kusavapo kwekupona. Gilteritinib inonyanya kusarudzwa FLT3 tyrosine kinase inhibitor iyo yakaratidza kuti ine basa rinopesana neFLT3 ITD mutations, uye inodzivisawo kuchinja kweFLT3 D835 iyo inogona kupa kliniki kushorwa kune mamwe FLT3 inhibitors.
Varwere makumi maviri nevaviri vakanyoresa muchikamu chekutanga che252 / 1 kuyedzwa kwakaratidza kuti 2% yevarwere vakadzokazve kana kuramba AML uye FLT49 shanduko dzakapindura gilteritinib. Hupenyu hwepakati pevatori vechikamu hwakapfuura mwedzi minomwe. Chete 3% yevarwere vasina FLT7 shanduko vakapindura gilteritinib, ichipa humbowo hwekuti inogona kushandiswa senge inosarudza inhibitor ye mutant FLT12.
Kubvumidzwa kwaive kwakavakirwa pane data kubva kuADMIRAL kudzidza, yakasarudzika danho 3 kutongwa uko 138 vakuru varwere vane FLT3- inodzokororazve / inodzora AML yakagamuchira 120 mg yemuromo gefitinib mazuva ese. Muboka iri, 21% yevarwere vakawana kuregererwa kwakakwana kana kuregererwa kwakakwana neparutivi hematological kupora. Muedzo weADMIRAL pachawo uchiri kuenderera mberi, uye mhinduro yakajeka uye data rezvekupona rese rinotarisirwa kuburitswa gore rinouya.
https://www.medscape.com/viewarticle/905713
