Agusta 2021: Infigratinib (Truseltiq, QED Therapeutics, Inc.), Mai hanawa kinase, an ba da izinin haɓakawa ta Cibiyar Abinci da Magunguna don manya waɗanda aka bi da su a baya, waɗanda ba za a iya gyara su ba a cikin gida ko kuma cholangiocarcinoma na metastatic tare da haɗin fibroblast girma factor 2 (FGFR2) fusion ko wani sake tsarawa kamar yadda aka gano ta hanyar gwajin da FDA ta amince da ita. .
FDA ta kuma amince da FoundationOne® CDx (Medicine Foundation, Inc.) a matsayin na'urar bincike na abokin aiki don maganin infigratinib a cikin marasa lafiya da haɗin FGFR2 ko ƙarin gyare -gyare.
CBGJ398X2204 (NCT02150967), gwajin gwaji mai hannu da hannu da yawa tare da marasa lafiya 108 tare da marasa lafiya na baya-bayan nan, wanda ba za a iya samun ci gaba a cikin gida ko metastatic cholangiocarcinoma tare da haɗin FGFR2 ko sakewa kamar yadda gwajin gida ko na tsakiya ya tabbatar, ya nuna inganci. Infigratinib 125 MG da baki sau ɗaya kowace rana don kwanaki 21, tare da biye da kwanaki 7 na warkewa, an ba marasa lafiya a cikin hawan keke na kwanaki 28 har zuwa ci gaban cutar ko guba mara karɓa.
Gabaɗaya ƙimar amsawa (ORR) da tsawon lokacin amsawa (DoR) sune matakan sakamako na farko na inganci, kamar yadda aka kafa ta makanta mai zaman kanta mai zaman kanta daidai da RECIST 1.1. Tare da cikakkiyar amsa 1 da martani guda 24, ORR shine 23% (95 bisa dari CI: 16, 32). Matsakaicin DoR shine watanni 5 (95 bisa dari CI: 3.7, 9.3). Takwas daga cikin masu amsawa 23 sun riƙe amsar su na tsawon watanni shida ko fiye.
Hyperphosphatemia, haɓaka creatinine, guba na ƙusa, stomatitis, bushewar ido, gajiya, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, maƙarƙashiya, ciwon ciki, bushewar baki, canjin gashin ido, zawo, bushewar fata, rage ci, hangen nesa ya ɓace, kuma amai su ne halayen da ba a saba gani ba (abin da ya faru 20%). Hyperphosphatemia da retina pigment epithelial detachment sune manyan haɗari, kuma yakamata a kula da marasa lafiya don waɗannan tasirin yayin magani.
Kuna so karanta: Maganin ciwon daji a Indiya
A cikin hawan keke na kwanaki 28, shawarar infigratinib da aka ba da shawarar ita ce 125 MG baki sau ɗaya a rana a kan komai a ciki na tsawon kwanaki 21, sannan kwanaki 7 daga shan magani.
reference: https://www.fda.gov/
Duba cikakkun bayanai nan.
