Agasti 2021: Infigratinib (Truseltiq, QED Therapeutics, Inc.), i-kinase inhibitor, inikezwe imvume esheshayo yi-Food and Drug Administration yabantu abadala abaphathwe ngaphambilini, abangenakulinganiswa endaweni ephakeme noma ye-metastatic cholangiocarcinoma ene-fibroblast growth factor receptor 2 (FGFR2) fusion noma okunye ukuhlela kabusha njengoba kutholwe ukuhlolwa okugunyazwe yi-FDA .
I-FDA iphinde yamukela i-FoundationOne® CDx (Foundation Medicine, Inc.) njengedivayisi yokuhlola yokuhambisana nokwelashwa kwe-infigratinib ezigulini ezine-FGFR2 fusion noma ukuhlelwa kabusha okungeziwe.
I-CBGJ398X2204 (i-NCT02150967), isilingo sesandla esisodwa esivulekile esinelebuli elilodwa neziguli eziyi-108 ezake zelashwa ngaphambilini, ezingenakulinganiswa ezithuthukiswe endaweni noma ezisemastastatic cholangiocarcinoma nge-FGFR2 fusion noma i-rearrangement njengoba kuqinisekiswe ukuhlolwa kwasendaweni noma okuphakathi, kukhombisa ukusebenza kahle. I-infigratinib 125 mg ngomlomo kanye ngosuku nsuku zonke izinsuku ezingama-21, ilandelwa yizinsuku eziyi-7 zokuphumula, yanikezwa iziguli ngemijikelezo yezinsuku ezingama-28 kuze kube ukuqhubekela phambili kwesifo noma ubuthi obungamukeleki.
Izinga lokuphendula selilonke (i-ORR) nobude besikhathi sokuphendula (i-DoR) bekuyizinyathelo eziyinhloko zomphumela wokusebenza ngempumelelo, njengoba kusungulwe ukubuyekeza okumaphakathi okuyimpumputhe ngokuya nge-RECIST 1.1. Ngempendulo ephelele ye-1 nezimpendulo ezingama-24, i-ORR yayingu-23% (95% CI: 16, 32). I-DoR emaphakathi bekuyizinyanga ezi-5 (amaphesenti angama-95 we-CI: 3.7, 9.3). Abaphenduli abayisishiyagalombili kwabangu-23 bagcine izimpendulo zabo izinyanga eziyisithupha noma ngaphezulu.
I-Hyperphosphatemia, i-creatinine eyandayo, ubuthi bezipikili, i-stomatitis, iso elomile, ukukhathala, i-alopecia, i-palmar-plantar erythrodysesthesia syndrome, i-arthralgia, i-dysgeusia, ukuqunjelwa, ubuhlungu besisu, umlomo owomile, ushintsho lwe-eyelash, isifo sohudo, isikhumba esomile, ukuncipha kwesifiso, ukubona kufiphele, futhi ukuhlanza kwakuyizindlela ezivame kakhulu ukuphika (izehlakalo ezingama-20%). I-Hyperphosphatemia kanye ne-retinal pigment epithelial detachment yizingozi ezinkulu, futhi iziguli kufanele ziqashwe ngale miphumela emibi ngesikhathi sokwelashwa.
Ungahle uthande ukufunda: Ukwelapha umdlavuza eNdiya
Emijikelezweni yezinsuku ezingama-28, umthamo we-infigratinib onconywayo ngu-125 mg ngomlomo kanye ngosuku esiswini esingenalutho izinsuku ezingama-21, kulandelwe izinsuku eziyi-7 zokuyeka imithi.
Izikhombo: https://www.fda.gov/
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