Nuwamba 2022: Pemigatinib (Pemazyre, Incyte Corporation) ya sami lasisi ta Hukumar Abinci da Magunguna don amfani a cikin mutanen da ke da koma baya ko myeloid/lymphoid neoplasms (MLNs) waɗanda ke da canjin fibroblast girma factor receptor 1 (FGFR1).
FIGHT-203 (NCT03011372), alamar buɗewa ta tsakiya, gwajin hannu ɗaya tare da marasa lafiya 28 waɗanda suka sake dawowa ko MLNs tare da sake tsara FGFR1, kimanta tasiri. Marasa lafiyan da suka cika ka'idojin cancanta ko dai ba su cancanci ko sun sake komawa bayan allogeneic hematopoietic stem cell transplantation (allo-HSCT) ko maganin gyara cuta (misali, chemotherapy). An ba da Pemigatinib har sai cutar ta ci gaba, mai guba ya zama wanda ba zai iya jurewa ba, ko kuma marasa lafiya na iya samun allo-HSCT.
Abubuwan da aka zaɓa da halayen asali sun haɗa da: 64% mace; 68% fari; 3.6% baki ko Ba'amurke; 11% Asiya; 3.6% Ba'amurke Ba'indiya/Dan Asalin Alaska; da 88% matsayin aikin ECOG na 0 ko 1. Matsakaicin shekarun ya kasance shekaru 65 (kewaye, 39 zuwa 78); 3.6% baki ko Ba'amurke; 68% fari; kuma 68% fari.
Dangane da cikakken ƙimar amsa (CR) waɗanda suka cika ka'idodin amsawa takamaiman ga nau'in cututtukan ƙwayoyin cuta, an ƙaddara inganci. 14 daga cikin marasa lafiya na 18 da ke fama da cutar extramedullary (EMD) da kuma lokaci mai tsawo a cikin bargo (78%; 95% CI: 52, 94) sun sami cikakkiyar gafara (CR). Matsakaicin adadin kwanakin zuwa CR shine 104. (kewaye, 44 zuwa 435). Matsakaicin lokacin (daga 1+ zuwa 988+ kwanaki) ba a kai ba. Biyu daga cikin marasa lafiya huɗu waɗanda ke da lokacin fashewa a cikin bargo tare da ko ba tare da EMD (lokaci: 1+ da 94 days) suna cikin gafara. Ɗaya daga cikin marasa lafiya uku waɗanda ke da EMD kadai sun sami CR (tsawon kwanaki 64+). Cikakken amsawar cytogenetic ga duk marasa lafiya na 28-ciki har da 3 ba tare da cututtukan ƙwayoyin cuta ba-ya kasance 79% (22/28; 95% CI: 59, 92).
Hyperphosphatemia, ƙusa yawan guba, alopecia, stomatitis, zawo, bushe ido, gajiya, rash, anemia, maƙarƙashiya, bushe baki, epistaxis, serous retinal detachment, extremity zafi, rage ci, bushe fata, dyspepsia, ciwon baya, tashin zuciya, blur hangen nesa. edema na gefe, da dizziness sune mafi yawan lokuta (20%) mummunan halayen da marasa lafiya suka fuskanta.
Rage phosphate, rage lymphocytes, rage leukocytes, rage platelets, dagagge alanine aminotransferase, da kuma rage neutrophils su ne mafi m Grade 3 ko 4 rashin daidaito dakin gwaje-gwaje (10%).
Ana ba da shawarar shan 13.5 MG na pemigatinib sau ɗaya kowace rana har sai cutar ta ci gaba ko kuma akwai guba maras iya jurewa.
View full prescribing information for Pemazyre.
