Novemba 2022: I-Pemigatinib (i-Pemazyre, i-Incyte Corporation) inikezwe ilayisense yi-Food and Drug Administration ukuze isetshenziswe kubantu abane-myeloid/lymphoid neoplasms (MLNs) ebuyele emuva noma e-refractory (MLNs) abane-fibroblast growth factor receptor 1 (FGFR1) eshintshiwe.
FIGHT-203 (NCT03011372), a multicenter open-label, single-arm trial with 28 patients who had relapsed or refractory MLNs with FGFR1 rearrangement, evaluated effectiveness. Patients who met the criteria for eligibility were either ineligible for or had relapsed following allogeneic hematopoietic stem cell transplantation (allo-HSCT) or a disease-modifying treatment (e.g., chemotherapy). Pemigatinib was given until the disease progressed, the toxicity became intolerable, or the patients could receive allo-HSCT.
Izibalo zabantu ezikhethiwe kanye nezici eziyisisekelo zihlanganisa okulandelayo: 64% abesifazane; 68% abamhlophe; 3.6% omnyama noma wase-Afrika waseMelika; I-11% yase-Asia; I-3.6% yamaNdiya aseMelika/abantu base-Alaska; kanye nesimo sokusebenza kwe-ECOG esingu-88% sika-0 noma 1. Iminyaka yobudala emaphakathi yayiyiminyaka engama-65 (ububanzi, 39 kuya ku-78); 3.6% omnyama noma wase-Afrika waseMelika; 68% abamhlophe; futhi 68% abamhlophe.
Ngokusekelwe kumazinga okuphendula okuphelele (CR) ahlangabezane nenqubo yokuphendula eqondene nohlobo lwesifo se-morphologic, ukusebenza kahle kwanqunywa. Iziguli ezingu-14 kwezingu-18 ezine-extramedullary disease (EMD) kanye nesigaba esingapheli emnkantsha (78%; 95% CI: 52, 94) bathole ukuxolelwa okuphelele (CR). Isilinganiso senani lezinsuku ku-CR sasiyi-104. (ububanzi, 44 kuya ku-435). Isikhathi esimaphakathi (kusuka ku-1+ ukuya ezinsukwini ezingama-988+) asifinyelelwanga. Iziguli ezimbili kwezine ezazinesigaba sokuqhuma kumnkantsha ezine-EMD noma ezingenayo (ubude besikhathi: 1+ kanye nezinsuku ezingu-94) zase zixolelwe. Esinye seziguli ezintathu ezazine-EMD sisodwa sabhekana ne-CR (izinsuku ezingama-64+ ezihlala njalo). Izinga eligcwele lokuphendula le-cytogenetic kuzo zonke iziguli ze-28-kuhlanganise ne-3 ngaphandle kwesifo se-morphologic-kwakuyi-79% (22/28; 95% CI: 59, 92).
I-Hyperphosphatemia, ubuthi bezinzipho, i-alopecia, i-stomatitis, isifo sohudo, iso elomile, ukukhathala, ukuqubuka, i-anemia, ukuqunjelwa, umlomo owomile, i-epistaxis, i-serous retinal detachment, ubuhlungu bomphetho, ukuncipha kwesifiso sokudla, isikhumba esomile, i-dyspepsia, iqolo, isicanucanu, ukungaboni kahle, i-peripheral edoema, kanye nesiyezi kwakuyizimo ezimbi kakhulu (20%) ezitholwa iziguli.
I-phosphate encishisiwe, ama-lymphocyte ancishisiwe, ama-leukocyte ancishisiwe, ama-platelet ancishisiwe, i-alanine aminotransferase ephakeme, kanye nama-neutrophil ancishisiwe kwakuyizinto ezingavamile kakhulu zeBanga lesi-3 noma le-4 laselabhorethri (10%).
Kunconywa ukuthatha i-13.5 mg ye-pemigatinib kanye ngosuku kuze kube yilapho isifo siqhubeka noma kunobuthi obungabekezeleleki.
View full prescribing information for Pemazyre.
