Iyo FDA yakabvumira eflornithine (IWILFIN, USWM, LLC) musi waZvita 13, 2023, kudzikisa njodzi yekudzokazve muvakuru nevana vane high-risk neuroblastoma (HRNB) vaive nechikamu chemhinduro kune yapfuura multiagent, multimodality therapy, senge anti-GD2 immunotherapy.
Izvi zvinoratidza kubvumidzwa kwekutanga kweFDA kwemushonga wakagadzirirwa kudzikisira mukana wekudzokazve muvarwere vechidiki vane HRNB.
Kubudirira kwakaongororwa mukuedza kwakaenzanisa migumisiro kubva kuChidzidzo 3b (boka rekuedza) neChidzidzo ANBL0032 (boka rekutonga kwekunze rakagadzirwa kubva mukuedza kwekliniki). Kudzidza 3b (NCT02395666) yaive yakawanda-yemuyedzo yaive yakavhurika label uye isina-randomized, yaisanganisira maviri cohorts. 105 varwere vanokodzera vane njodzi yakanyanya neuroblastoma kubva kune rimwe boka (Stratum 1) vakapiwa eflornithine nemuromo, kaviri zuva nezuva pamuyero wakatarwa nemuviri wepamusoro (BSA) kusvikira kufambira mberi kwechirwere, huturu husingagamuchirwi, kana kwepamusoro pemakore maviri. Chidzidzo 2b chakarongwa pachine nguva kuenzanisa zvakabuda nenhoroondo yekupona mahara (EFS) mwero kubva kuChidzidzo ANBL3 sekutaurwa kwazvinoitwa mumabhuku akadhindwa.
Kudzidza ANBL0032 yaive yakawanda-kati, yakavhurika-label, randomized muyedzo wakaenzanisa dinutuximab, granulocyte-macrophage colony-stimulating factor, interleukin-2, uye cis-retinoic acid kune cis-retinoic asidhi chete muvana varwere vane njodzi yakanyanya neuroblastoma. Ruoko rwekunze rwekudzora rwakanga rwakavakirwa pane data kubva kuvarwere ve1,241 muruwoko rwekuyedza.
Varwere vakasangana nemaitiro ekufananidza pakati peChidzidzo 3b ne ANBL0032 uye vaive nedata rakazara kune mamwe makiriniki covariates akapetwa muchiyero che3: 1 zvichienderana nekwavo zvibodzwa. Ongororo yekutanga yaisanganisira varwere makumi mapfumbamwe vakarapwa neIWILFIN uye 90 kudzora varwere kubva kuChidzidzo ANBL270.
Chiyero chekutanga chekubudirira kwaive kupona-kusina chiitiko (EFS), iyo yaisanganisira kufambira mberi kwechirwere, kudzokazve, kurwara kwechipiri, kana kufa kubva kune chero chikonzero. Imwe metric inoshanda yaive kupona kwese (OS), iyo yakatsanangurwa serufu kubva kune chero chikonzero. EFS hazard ratio (HR) muongororo yekutanga yaive 0.48 ine 95% nguva yekuvimba (CI) ye0.27 kusvika 0.85. Iyo OS HR yaive 0.32 ine 95% CI ye0.15 kusvika 0.70. Nekuda kwekusava nechokwadi mukufungidzira kurapwa kunouya nekunze kwakadzorwa dhizaini yekutsvagisa, kumwe kuongorora kwakaitwa pane subpopulations kana kushandisa nzira dzakasiyana dzenhamba. EFS HR yakasiyana pakati pe0.43 (95% CI: 0.23, 0.79) uye 0.59 (95% CI: 0.28, 1.27), nepo OS HR yakabva ku0.29 (95% CI: 0.11, 0.72) kusvika ku0.45% 95: 0.21 0.98, XNUMX).
MuChidzidzo 3b, mhedzisiro yakajairika (≥5%), iyo yaisanganisira kusajairika kwerabhu, yaive mhino yakakanuka, manyoka, chikosoro, sinusitis, mabayo, hutachiona hwepamusoro hwekufema, conjunctivitis, kurutsa, fivha, allergic rhinitis, neutrophils yakaderera, yakakwirira ALT uye AST, kurasikirwa kwekunzwa, utachiona hweganda, uye weti tract infection.
kenza
Lutetium Lu 177 dotatate inotenderwa neUSFDA kune vana vane makore gumi nemaviri zvichikwira neGEP-NETS.
Lutetium Lu 177 dotatate, kurapwa kwepasi, ichangobva kugamuchira mvumo kubva kuUS Food and Drug Administration (FDA) yevarwere vevana, zvichiratidza chiitiko chakakosha muvana oncology. Mvumo iyi inomiririra chiedza chetariro kuvana vari kurwisana neuroendocrine tumors (NETs), isingawanzowanikwi asi inonetsa yegomarara iro rinowanzoratidza kuti rinoshingirira pakurapa kwakajairika.
Alysha Mendossa
Dai 11, 2024
