November 2022: Chikafu neDrug Administration yakapa kukurumidza kubvumidzwa kune futibatinib (Lytgobi, Taiho Oncology, Inc.) kuvarwere vakura vakamborapwa, vasingadzokerike, venzvimbo yepamusoro kana metastatic intrahepatic cholangiocarcinoma inochengetera fibroblast growth factor receptor 2 (FGFR2) gene fusions kana zvimwezve kugadzirisa.
Kubudirira kwakaongororwa muTAS-120-101 (NCT02052778), yakawanda-yakavhurika-label, imwe-ruoko ruyedzo iyo yakanyoresa varwere ve103 vakamborapwa, vasina kudzivirirwa, vemunharaunda yepamusoro, kana metastatic intrahepatic cholangiocarcinoma inochengeta a FGFR2 regenerangement. Kuvepo kweFGFR2 fusions kana kumwe kurongeka kwakatemwa uchishandisa chizvarwa chinotevera chekuenzanisa kuyedzwa. Varwere vakagamuchira 20 mg ye futibatinib nemuromo kamwe chete zuva rega rega kusvikira kufambira mberi kwechirwere kana kusvibiswa kusingagamuchirwi.
Iwo makuru ekubudirira mhedzisiro matanho aive akazara mhinduro mwero (ORR) uye nguva yekupindura (DoR) sezvakatemwa nekomiti yakazvimirira yekuongorora maererano neRECIST v1.1. ORR yaiva 42% (95% Confidence Interval [CI]: 32, 52); vese 43 vakapindura vakawana zvishoma mhinduro. Iyo yepakati DoR yaive 9.7 mwedzi (95% CI: 7.6, 17.1).
Maitiro akajairika anoitika mu20% kana kupfuura evarwere aive huturu hwembambo, kurwadziwa kwemusculoskeletal, kuvimbiswa, manyoka, kuneta, muromo wakaoma, alopecia, stomatitis, kurwadziwa mudumbu, ganda rakaoma, arthralgia, dysgeusia, ziso rakaoma, kusvotwa, kuderera kwechido. , chirwere cheweti, palmar-plantar erythrodysesthesia syndrome, uye kurutsa.
Iyo yakakurudzirwa futibatinib dose ndeye 20 mg muromo kamwe chete zuva nezuva kusvikira kufambira mberi kwechirwere kana kusingagamuchirwi chepfu kuchiitika.
View full prescribing information for Lytgobi.
