Isidakamizwa se-leukemia esaziwa yi-FDA njengokwelashwa okuphumelelayo

Yabelana ngalokhu okuthunyelwe

I-FDA inikeze umuthi wayo wempumelelo imibuzo quibartinib a ukwelashwa ngentuthuko. I-Quizartinib is a I-FLT3 i-inhibitor engaphansi kophenyo yokwelashwa kweziguli ezikhulile ezibuyele emuva refractory I-FLT3-ITD i-acute myeloid leukemia ( I-AML ). Lokhu kuhlonza kuzosheshisa ukuthuthukiswa kwe quizartinib futhi kulindeleke ukuthi ilethe imishanguzo emisha ezigulini ngokushesha okukhulu.

I-AML inonya 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 igama leziguli ezintsha ezitholakele, nokungaphezulu kwe- 10000 Ge I-AML ukufa. I 2005-2011 imiphumela yocwaningo ikhombisa ukuthi 5- izinga lokusinda konyaka I-AML iziguli kuphela 26% , okuyisibalo esiphansi kunazo zonke izinhlobo ze-leukemia. I-FLT3 ukuguqulwa kwezakhi zofuzo ukuguqulwa kofuzo okuvamile kakhulu I-AML iziguli, ngenkathi I-FLT3-ITD ukuguqulwa okuvamile kakhulu kwe- I-FLT3 gene, futhi cishe ingxenye yesine ye- I-AML iziguli zithwala lokhu kuguquka. Uma kuqhathaniswa neziguli ezingazange zikuthwale lokhu kuguquka, iziguli ezine- I-FLT3-ITD ukuguqulwa kwezakhi zofuzo kwaba nokubikezelwa okubi kakhulu, ingozi enkulu yokuphinda umdlavuza, kanye nengozi enkulu yokufa ngemva kokuphinda. Noma ngabe lezi ziguli zithola ukufakelwa kwe-hematopoietic stem cell ( I-HSCT ), ithuba lokuphindaphinda komdlavuza ngemuva kokwelashwa lisaphakeme kunalelo leziguli ezingakuthwali lokhu kuguquka. Njengamanje, ayikho indlela yokwelashwa evunyelwe yalesi sifo. Ngakho-ke, lokhu kwelashwa okuphumelelayo kulindeleke ukuthi kulethe ithemba elisha ezigulini ezine I-FLT3-ITD .

Ngaphezu kokuhlonza ukwelashwa okuphumelelayo, quizartinib futhi wathola FDA ithrekhi esheshayo yokufaneleka yokubuyela emuva refractory I-AML therapy, kanye neziqu zomuthi wezintandane I-AML Kukhishwe ngu FDA kanye ne-European Medicines Agency ( EMA ). Quizartinib kuyinto kusasesigabeni socwaningo nentuthuko futhi akuvunyelwe kunoma yiliphi izwe. Ukuphepha nokubekezelelana kusamele kuqinisekiswe. Kodwa-ke, lokhu kuvunyelwa kulindeleke ukuthi kusheshise ukuthuthukiswa komuthi, okuyizindaba ezinhle ngempela ezigulini.

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