The FDA yakapa mushonga wayo wekubudirira quizartinib a kubudirira kurapwa. Quizartinib ndiwo FLT3 inhibitor pasi pekuferefetwa kwekurapa kwevarwere vakura vane kudzokazve / refractory FLT3-ITD acute myeloid leukemia ( AML ) Kuzivikanwa uku kuchaita kuti kukura kwe quizartinib uye inotarisirwa kuunza mishonga mitsva kuvarwere nekukurumidza sezvazvinogona.
AML ane utsinye blood and bone marrow cancer that causes dysfunctional cancerous leukocytes to proliferate and accumulate uncontrollably, and affects the production of normal blood cells. The United States this year is expected to have more than 19000 zita revarwere vatsva vakaongororwa, uye zvinopfuura 10000 Ge AML rufu. The 2005-2011 ongororo yakaitwa inoratidza kuti 5- gore rekurarama rate ye AML varwere chete 26% , inova iyo yakaderera pakati pemhando dzose dzeleukemia. FLT3 gene mutation is the most common genetic mutation in AML varwere, nepo FLT3-ITD ndiyo inonyanya kushandurwa kwe FLT3 geni, uye chinenge chikamu chechina che AML varwere vanotakura shanduko iyi. Kuenzaniswa nevarwere vasina kutakura shanduko iyi, varwere vane FLT3-ITD mutations had a worse prognosis, a higher risk of cancer recurrence, and a greater risk of death after relapse. Even if these patients receive a hematopoietic stem cell transplant ( HSCT ), mukana wekenza unodzokazve mushure mekurapwa uchiri wakakwirira kupfuura uya wevarwere vasina kutakura shanduko iyi. Parizvino, hapana kurapwa kwakabvumidzwa kwechirwere ichi. Naizvozvo, kurapa kwekubudirira uku kunotarisirwa kuunza tariro nyowani kuvarwere vane FLT3-ITD .
Pamusoro peiyo budiriro yekurapa kuzivikanwa, quizartinib akagashirawo FDA kukurumidza-track qualification yekudzokazve / refractory AML kurapwa, uye hunhu hwemishonga yenherera AML yakabudiswa ne FDA uye iyo European Medicines Agency ( EMA ). Quizartinib iri vachiri muchikamu chekutsvaga nekusimudzira uye hachina kubvumidzwa mune chero nyika. Kudzivirirwa uye kushivirira hazvisati zvichisimbiswa. Nekudaro, iyi mvumo inotarisirwa kuti ikwidziridze kuvandudzwa kwemushonga, inova inhau dzakanaka dzevarwere.
