Nofeembar 2022: Maamulka Cuntada iyo Dawooyinka ayaa siisay oggolaan degdeg ah futibatinib (Lytgobi, Taiho Oncology, Inc.) ee bukaannada qaangaarka ah ee hore loo daaweeyay, aan la daweyn karin, degaanka horumarsan ama metastatic intrahepatic cholangiocarcinoma oo xajiya fibroblast factor factor receptor 2 (FGFR2) fusions gene ama dib u habeyn kale.
Waxtarka waxaa lagu qiimeeyay TAS-120-101 (NCT02052778), xarun badan, calaamad furan, tijaabo hal gacan ah oo diiwaan gashan 103 bukaan oo hore loo daaweeyay, aan la daweyn karin, deegaanka horumaray, ama metastatic cholangiocarcinoma intrahepatic cholangiocarcinoma oo xajinaysa isku-dhafka hidde-sideyaasha FGFR2 Jiritaanka isku-dhafka FGFR2 ama dib-u-habayn kale ayaa lagu go'aamiyay iyadoo la isticmaalayo tijaabinta isku xigxiga ee jiilka xiga. Bukaan-socodka ayaa qaatay 20 mg oo futibatinib afka ah hal mar maalintii ilaa cudurku ka sii socdo ama sunta aan la aqbali karin.
Tallaabooyinka waxtarka leh ee ugu weyn waxay ahaayeen heerka jawaabta guud (ORR) iyo muddada jawaabta (DoR) sida ay go'aamiyeen guddiga dib u eegista madax-bannaan sida uu qabo RECIST v1.1. ORR wuxuu ahaa 42% (95% Kalsoonida Dhexdhexaadinta [CI]: 32, 52); dhammaan 43-da jawaabeyaashu waxay heleen jawaabo qayb ahaan. Dhexdhexaadka DoR wuxuu ahaa 9.7 bilood (95% CI: 7.6, 17.1).
Dareen-celinta xun ee ugu badan ee ku dhacda 20% ama in ka badan bukaanada ayaa ah sunta ciddiyaha, xanuunka murqaha, calool-istaagga, shuban, daal, afka qalalan, alopecia, stomatitis, calool xanuun, maqaarka qalalan, arthralgia, dysgeusia, isha qalalan, lallabbo, rabitaanka cuntada oo yaraatay. , caabuqa kaadi mareenka, palmar-plantar erythrodysesthesia syndrome, iyo matag.
Qiyaasta futibatinib ee lagu taliyey waa 20 mg afka hal mar maalintii ilaa cudurku ka sii socdo ama sunta aan la aqbali karin ay dhacdo.
View full prescribing information for Lytgobi.
