Yuli 2022: Crizotinib (Xalkori, Pfizer Inc.) an ba da izini ta Cibiyar Abinci da Magunguna (FDA) don kula da tsofaffi da marasa lafiya na yara masu shekaru 1 da haihuwa waɗanda aka gano tare da rashin daidaituwa, mai maimaitawa, ko refractory kumburi anaplastic lymphoma kinase (ALK) -Tabbataccen ciwace-ciwacen daji na myofibroblastic wadanda ke da inganci ga ALK (IMT).
Dukansu aminci da inganci na crizotinib an kimanta su a cikin nau'i biyu daban-daban na multicenter, hannu-ɗaya, gwajin alamar buɗaɗɗen. Waɗannan gwaje-gwajen sun haɗa da marasa lafiya na yara da manya waɗanda ba a sake su ba, masu maimaitawa, ko masu ƙin yarda da ALK-tabbatacce IMT. Marasa lafiya na yara sun shiga gwaji ADVL0912 (NCT00939770), yayin da manya marasa lafiya suka shiga gwaji A8081013 (NCT01121588).
Maƙasudin martani na haƙiƙa shine farkon alamar inganci wanda aka auna a cikin waɗannan gwaji (ORR). An sami amsa mai ma'ana a cikin 12 daga cikin 14 marasa lafiya na yara (wanda ya dace da ƙimar nasara na 86% tare da tazarar amincewar 95% daga 57% zuwa 98%) lokacin da kwamitin nazari mai zaman kansa ya kimanta marasa lafiya. Biyar daga cikin manya marasa lafiya bakwai sun nuna alamun ci gaba.
Alamomin amai, tashin zuciya, gudawa, ciwon ciki, kurji, matsalar hangen nesa, kamuwa da cutar numfashi ta sama, tari, pyrexia, ciwon musculoskeletal, gajiya, edoema, da maƙarƙashiya sune mafi yawan halayen halayen marasa lafiya (kashi 35) a cikin marasa lafiya na yara. A cikin manya marasa lafiya, cututtukan hangen nesa, tashin zuciya, da kuma edoema sune mummunan halayen da suka faru akai-akai fiye da kashi talatin da biyar na lokaci.
Ya kamata a yi amfani da Crizotinib baki sau biyu a kowace rana a kashi na 250 milligrammes (MG) a cikin manya marasa lafiya har sai cutar ta yi tsanani ko kuma rashin yarda da guba ya kai. Bayar da 280 mg/m2 a baki sau biyu a kowace rana shine maganin yara wanda aka ba da shawarar har sai cutar ta ci gaba ko kuma rashin yarda da guba ya faru.
View full prescribing information for Xalkori.
