Munguva pfupi yapfuura, GenFleet Therapeuticsyakazivisa kuti Pharmaceutical Administration Bureau (ISAF) yeMacau Special Administrative Region yeChina yabvumidza Dupert®（fulzerasib, GFH925/IBI351）kurapa varwere vane advanced non-small cell lung cancer (NSCLC) vane KRAS G12C mutation avo vakagamuchira kanenge kamwe chete kurapwa kwemuviri.
Fulzerasib ndiyo yekutanga mushonga weKRAS G12C wakagadzirwa neChina uyo wakatenderwa neNDA nePriority Review Designation muna Nyamavhuvhu 2024 neNMPA.
Nezve Dupert® (fulzerasib, KRAS G12C Inhibitor)
Yakawanikwa neGenFleet Therapeutics, fulzerasib (GFH925/IBI351) mushonga mutsva, unoshanda nemuromo, une simba weKRAS G12C inhibitor wakagadzirirwa kunanga zvinobudirira kuchinjana kweGTP/GDP, danho rakakosha mukushanda kwenzira, nekushandura mapuroteni eKRAS G12C ecysteine pamwe chete uye zvisingadzoreki. Zvidzidzo zvekusarudza cysteine zvepamberi pekiriniki zvakaratidza kusarudza kwakanyanya kweGFH925 kuenda kuG12C. Zvadaro, GFH925 inodzivirira zvinobudirira nzira yechiratidzo yekudzika kuti ikonzere apoptosis yemasero egomarara uye kumisa kutenderera kwemasero.
Fulzerasib yakawanawo kurudziro yeKirasi 1 mukurapa KRAS G12C-mutant NSCLC mugwara reCSCO ra2025, ichipa varwere sarudzo itsva yekurapa kwakanangana nekushanda kwenguva refu uye kushivirira kwakanaka.
Zvichienderana nedata rechikamu chechipiri cheongororo yekunyoresa pakati pevarwere vane KRAS G12C mutant NSCLC, fulzerasib monotherapy yakawana ORR ye49.1% uye avhareji yePFS yemwedzi 9.7; mwero weOS wemwedzi gumi nemiviri waive 54.4%, uye mwero weDoR wemwedzi gumi nemiviri waive 53.7%. Monotherapy yakapihwawo maBreakthrough Therapy Designations maviri ekurapa varwere veKRAS G12C-mutant NSCLC nevarwere vekenza ye colorectal.
Ichitungamirwa neGenFleet pamwe chete nenyanzvi dzepamusoro dzekenza yemapapu muEurope, chidzidzo cheKROCUS chefulzerasib pamwe chete necetuximab chakaratidzawo kushanda kwakanaka kune vese varwere vekutanga veNSCLC uye kunyanya mhinduro yakanaka yegomarara pakati pevarwere vane gomarara muuropi. Pamusoro pezvo, chirongwa ichi chakaratidza kuchengetedzeka/kushivirira kuri nani pane fulzerasib monotherapy mukurapa kwechipiri uye pamusoro peNSCLC. Semusanganiswa wekutanga weKRAS G12C inhibitor (fulzerasib) uye anti-EGFR antibody (cetuximab) mukurapa gomarara remapapu kwemutsara wekutanga, nzira iyi itsva ine mukana wekugadzira SOC yechizvarwa chinotevera yekurapa kwemutsara wekutanga weNSCLC.
Zvichienderana nedata riri muchidimbu chekupedzisira pamusangano wepagore weEuropean Lung Cancer Conference (ELCC) we2025, vatori vechikamu makumi mana nevashanu vakaongororwa bundu mushure mekurapwa musi wa14 Ndira muna 2025: ORR yakasvika 80%; DCR yakasvika 100%; mPFS yaive mwedzi gumi nemiviri nehafu.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
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Email：myimmnet@163.com
Nguva yekutumira: Chikunguru-15-2025