Nyamavhuvhu 2021: Infigratinib (Truseltiq, QED Therapeutics, Inc.), kinase inhibitor, yakapihwa kukurumidza kubvumidzwa neChikafu neDrug Administration kune vanhu vakuru vakamborapwa, isingatariswe munharaunda yepamusoro kana metastatic cholangiocarcinoma ine fibroblast growth factor receptor 2 (FGFR2) fusion kana kumwe kurongeka zvakare sekuonekwa neFDA-yakatenderwa bvunzo. .
Iyo FDA zvakare yakabvumidza FoundationOne® CDx (Foundation Mushonga, Inc.) seshamwari yekuongorora chishandiso che infigratinib kurapwa mune varwere vane FGFR2 fusion kana mamwe marongero zvakare.
CBGJ398X2204 (NCT02150967), multicenter open-label single-ruoko kutongwa nevarwere ve108 vakamborapwa, vasingadzoreke munzvimbo yepamusoro kana metastatic cholangiocarcinoma ine FGFR2 fusion kana rearrangement sekusimbiswa nemiedzo yemuno kana yepakati, yakaratidza kushanda. Infigratinib 125 mg muromo kamwe chete zuva nezuva kwemazuva makumi maviri nemana, zvichiteverwa nemazuva manomwe kubva kuchirapa, zvakapihwa kuvarwere mumazuva makumi maviri nemasere kusvika pakurwara kwechirwere kana chepfu isingagamuchirike.
Yakazara yekupindura mwero (ORR) uye nguva yekupindura (DoR) yaive ekutanga maitiro emhedzisiro matanho, sekugadzwa neakavharwa akazvimiririra epakati ongororo maererano neRECIST 1.1. Iine 1 mhinduro yakazara uye makumi maviri nesere mhinduro, iyo ORR yaive 24% (23 muzana CI: 95, 16). Ivhareji DoR yaive mwedzi mishanu (32 muzana CI: 5, 95). Vasere vevapindura makumi maviri nevatatu vakachengeta mhinduro yavo kwemwedzi mitanhatu kana kupfuura.
Hyperphosphatemia, yakawedzera creatinine, chipikiri chepfu, stomatitis, ziso rakaoma, kuneta, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, kupatirwa, kurwadziwa mudumbu, muromo wakaoma, eyelash shanduko, manyoka, ganda rakaoma, kuderera kwechido, kuona kwakasviba, uye kurutsa ndiko kwakajairika kusagadzikana (zviitiko 20%). Hyperphosphatemia uye retinal pigment epithelial detachment ingozi huru, uye varwere vanofanirwa kuongororwa nezveiyi mhedzisiro panguva yekurapa.
Unogona kuda kuverenga: Kenza kurapwa muIndia
Mumazuva makumi maviri nemasere, iyo inokurudzirwa infigratinib dose ndeye 28 mg muromo kamwe chete pazuva pane isina chinhu kwemazuva makumi maviri nerimwe, ichiteverwa nemazuva manomwe kubva pamushonga.
Dheuteronomio: https://www.fda.gov/
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