Nuwamba 2022: Hukumar Abinci da Magunguna ta ba da izinin haɓaka ga futibatinib (Lytgobi, Taiho Oncology, Inc.) don manya marasa lafiya waɗanda aka yi musu magani a baya, waɗanda ba za a iya gyara su ba, ci gaba a cikin gida ko metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions ko wasu sake shiryawa.
An kimanta inganci a cikin TAS-120-101 (NCT02052778), multicenter, buɗaɗɗen lakabin, gwajin hannu guda ɗaya wanda ya yi rajistar marasa lafiya 103 waɗanda aka yi musu magani a baya, waɗanda ba a sake su ba, ci gaba a cikin gida, ko metastatic intrahepatic cholangiocarcinoma wanda ke ɗauke da jigon halittar FGFR2 ko wasu sake dawowa. An ƙaddara kasancewar haɗin FGFR2 ko wasu sake tsarawa ta amfani da gwajin jerin tsararru na gaba. Marasa lafiya sun karɓi 20 MG na futibatinib baki ɗaya sau ɗaya kowace rana har sai cutar ta ci gaba ko kuma rashin yarda da guba.
Babban ma'aunin sakamako na tasiri shine jimlar amsawa (ORR) da tsawon lokacin amsawa (DoR) kamar yadda kwamitin nazari mai zaman kansa ya ƙaddara bisa ga RECIST v1.1. ORR ya kasance 42% (95% Tsakanin Amincewa [CI]: 32, 52); duk masu amsawa 43 sun sami amsoshi kaɗan. DoR na tsakiya shine watanni 9.7 (95% CI: 7.6, 17.1).
Mafi yawan halayen halayen da ke faruwa a cikin 20% ko fiye na marasa lafiya sune guba na ƙusa, ciwo na musculoskeletal, maƙarƙashiya, zawo, gajiya, bushe baki, alopecia, stomatitis, ciwon ciki, bushe fata, arthralgia, dysgeusia, bushe ido, tashin zuciya, rage ci. , ciwon urinary fili, palmar-plantar erythrodysesthesia syndrome, da amai.
Adadin futibatinib da aka ba da shawarar shine 20 MG na baki sau ɗaya kowace rana har sai cutar ta ci gaba ko kuma cutar da ba a yarda da ita ta faru.
View full prescribing information for Lytgobi.
