Ogosto 2021: Infigratinib (Truseltiq, QED Therapeutics, Inc.), Kinase inhibitor, ayaa la siiyay oggolaan degdeg ah Maamulka Cuntada iyo Dawooyinka ee dadka qaangaarka ah ee hore loo daaweeyay, aan la sixi karin ama cholangiocarcinoma maxalli ah oo horumarsan ama metastatic cholangiocarcinoma oo leh fayraska koritaanka fibroblast 2 (FGFR2) ama dib u habeyn kale sida lagu ogaaday baaritaanka FDA-ansixisay .
FDA waxay kaloo ansixisay FoundationOne® CDx (Foundation Medicine, Inc.) sidii qalab lagu ogaanayo saaxiibka oo loogu talagalay daawaynta infigratinib ee bukaanada leh FGFR2 fusion ama dib u habeyn dheeraad ah.
CBGJ398X2204 (NCT02150967), tijaabo hal gacan ah oo furan oo xarumo badan leh oo leh 108 bukaan oo hore loo daaweeyay, aan la daweyn karin oo gudaha ah ama cholangiocarcinoma metastatic oo leh FGFR2 fiyuus ama dib u habeyn sida lagu caddeeyey imtixaanada maxaliga ah ama dhexe, oo muujiyay waxtarnimada. Infigratinib 125 mg afka hal mar maalin kasta 21 maalmood, oo ay ku xigto 7 maalmood oo daawaynta ah, ayaa la siiyay bukaannada wareegyada 28-maalin ilaa cudurku ka sii socdo ama sunta aan la aqbali karin.
Heerka jawaabta guud (ORR) iyo muddada jawaabta (DoR) waxay ahaayeen cabbirada natiijada waxtarka aasaasiga ah, sida lagu dejiyay dib-u-eegis dhexe oo madax-bannaan oo indho la' oo waafaqsan RECIST 1.1. Iyadoo 1 jawaab celin dhamaystiran iyo 24 jawaabaha qayb ahaan, ORR ahaa 23% (95 boqolkiiba CI: 16, 32). Celceliska DoR wuxuu ahaa 5 bilood (95 boqolkiiba CI: 3.7, 9.3). Siddeed ka mid ah 23-kii jawaab bixiye waxay haysteen jawaabtooda lix bilood ama ka badan.
Hyperphosphatemia, creatinine kordhay, sumoobo ciddiyaha, stomatitis, isha qalalan, daal, alopecia, palmar-plantar erythrodysesthesia syndrome, arthralgia, dysgeusia, calool-istaagga, calool xanuun, afka qalalan, isha isbedel, shuban, maqaarka qalalan, rabitaanka cuntada oo yaraada, aragga oo xumaaday, iyo mataggu waxay ahaayeen falcelinta xun ee ugu badan (dhacdooyinka 20%). Hyperphosphatemia iyo kala goynta midabka isha ee epithelial waa khataro waaweyn, bukaanada waa in lala socdo dhibaatooyinkan soo raaca inta lagu jiro daawaynta.
Waxaa laga yaabaa inaad jeceshahay inaad akhriso: Daweynta Kansarka ee Hindiya
Wareegyada 28-maalmood, qiyaasta infigratinib ee lagu taliyey waa 125 mg afka hal mar maalintii calool madhan 21 maalmood, oo ay ku xigto 7 maalmood oo daawo ah.
Tixraaca: https://www.fda.gov/
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