Novemba 2022: I-Food and Drug Administration inikeze ukugunyazwa okusheshisiwe kwe-fubatinib (Lytgobi, Taiho Oncology, Inc.) ezigulini ezikhulile ezinokuhlanganiswa kofuzo okuye kwalashwa ngaphambilini, okungahlehki, okuthuthukisiwe noma okune-metastatic intrahepatic intrahepatic intrahepatic ephethe i-fibroblast growth factor receptor 2 (FGFR2) noma okunye ukulungiswa kabusha.
Ukusebenza kahle kuye kwahlolwa ku-TAS-120-101 (NCT02052778), isivivinyo se-multicenter, open-lebula, ingalo eyodwa esabhalisa iziguli eziyi-103 ezazinokwelashwa kwangaphambilini, okungahlehlisiwe, okuthuthukile endaweni, noma i-metastatic intrahepatic cholangiocarcinoma efukamele i-FGFR2 yokukhiqiza kabusha. Ukuba khona kokuhlanganiswa kwe-FGFR2 noma okunye ukuhlela kabusha kwanqunywa kusetshenziswa ukuhlolwa kokulandelana kwesizukulwane esilandelayo. Iziguli zithole i-20 mg ye-fubatinib ngomlomo kanye ngosuku kuze kube yilapho isifo siqhubeka noma ubuthi obungamukeleki.
Izinyathelo ezinkulu zemiphumela yokusebenza ngempumelelo kwakuyizinga lokuphendula lilonke (ORR) kanye nobude besikhathi sokuphendula (DoR) njengoba kunqunywe ikomiti elizimele lokubuyekeza ngokuya nge-RECIST v1.1. I-ORR yayingu-42% (95% Isikhathi Sokuqiniseka [CI]: 32, 52); bonke abaphenduli abangu-43 bathole izimpendulo eziyingxenye. I-DoR emaphakathi yayiyizinyanga ezingu-9.7 (95% CI: 7.6, 17.1).
Imiphumela emibi evame kakhulu eyenzeka ku-20% noma ngaphezulu weziguli ubuthi bezinzipho, ubuhlungu bemisipha namathambo, ukuqunjelwa, isifo sohudo, ukukhathala, umlomo owomile, i-alopecia, i-stomatitis, ubuhlungu besisu, isikhumba esomile, i-arthralgia, i-dysgeusia, iso elomile, isicanucanu, ukuncipha kwesifiso sokudla. , ukutheleleka komgudu womchamo, i-palmar-plantar erythrodysesthesia syndrome, nokuhlanza.
Umthamo onconywayo we-fubatinib ngu-20 mg ngomlomo kanye ngosuku kuze kube yilapho kwenzeka ukukhula kwesifo noma ubuthi obungamukeleki.
View full prescribing information for Lytgobi.
