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I-Crizotinib ivunyelwe yi-FDA ye-ALK-positive inflammatory myofibroblastic tumor

Yabelana ngalokhu okuthunyelwe

Crizotinib

 

Julayi 2022: I-Crizotinib (i-Xalkori, i-Pfizer Inc.) inikezwe imvume yi-Food and Drug Administration (FDA) yokwelapha iziguli ezindala kanye nezingane ezineminyaka engu-1 ubudala nangaphezulu ezitholwe zine-anaplastic lymphoma kinase engathandeki, ephindaphindayo, noma ephikisayo (ALK). ) -izicubu ze-myofibroblastic ezinhle ezazihle ku-ALK (IMT).

Kokubili ukuphepha nokusebenza ngempumelelo kwe-crizotinib kwahlolwa ezivivinyweni ezimbili ezihlukene ze-multicenter, ingalo eyodwa, ilebula evulekile. Lezi zivivinyo zazihlanganisa kokubili iziguli zezingane nezabantu abadala ezine-IMT engabukeki, ephindaphindayo, noma ephikisayo ye-ALK-positive. Iziguli zezingane zibambe iqhaza ocwaningweni lwe-ADVL0912 (NCT00939770), kuyilapho iziguli ezindala zibambe iqhaza ocwaningweni A8081013 (NCT01121588).

Izinga lokuphendula okuhlosiwe laliyinkomba eyinhloko yokusebenza kahle eyalinganiswa kulezi zivivinyo (ORR). Impendulo ehlosiwe itholwe ezigulini zezingane eziyi-12 kweziyi-14 (okuhambisana nezinga lempumelelo elingama-86% nesikhathi sokuzethemba esingu-95% esisuka ku-57% kuya ku-98%) lapho iziguli zihlolwa yikomiti elibuyekezayo elizimele. Iziguli ezinhlanu kweziyisikhombisa zabantu abadala zibonise izimpawu zokuthuthuka.

Izimpawu zokuhlanza, isicanucanu, isifo sohudo, izinhlungu zesisu, ukuqubuka, ukuphazamiseka kokubona, ukutheleleka ngepheshana lokuphefumula eliphezulu, ukukhwehlela, i-pyrexia, ubuhlungu bemisipha namathambo, ukukhathala, i-edoema, nokuqunjelwa kwakuyizimo ezimbi kakhulu (amaphesenti angama-35) ezigulini zezingane. Ezigulini ezikhulile, ukuphazamiseka kokubona, isicanucanu, kanye ne-edoma kwakuyizimo ezimbi ezenzeka kaningi kunamaphesenti angamashumi amathathu nanhlanu esikhathi.

I-Crizotinib kufanele inikezwe ngomlomo kabili ngosuku ngethamo lama-250 milligrammes (mg) ezigulini ezikhulile kuze kube yilapho isifo siba sibi kakhulu noma ubuthi obungamukeleki bufinyelelwa. Ukunikeza ngomlomo u-280 mg/m2 kabili ngosuku umthamo wezingane onconywayo kuze kube yilapho kuvela ukukhula kwesifo noma ubuthi obungamukeleki.

View full prescribing information for Xalkori.

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