Posachedwapa, GenFleet TherapeuticsBungwe Loona za Mankhwala ku Macau ku China lalengeza kuti lavomereza Dupert®（fulzerasib, GFH925/IBI351）kuti lichiritse odwala omwe ali ndi khansa ya m'mapapo ya non-small cell (NSCLC) yomwe ili ndi KRAS G12C mutation omwe adalandira chithandizo chimodzi chamankhwala.
Fulzerasib inali mankhwala oyamba oletsa matenda a KRAS G12C opangidwa ku China omwe adavomerezedwa ndi NDA ndi Priority Review Designation mu Ogasiti 2024 ndi NMPA.
Zokhudza Dupert® (fulzerasib, KRAS G12C Inhibitor)
Yopezeka ndi GenFleet Therapeutics, fulzerasib (GFH925/IBI351) ndi mankhwala atsopano, ogwiritsidwa ntchito pakamwa, komanso amphamvu a KRAS G12C omwe adapangidwa kuti azitha kusinthana bwino ndi GTP/GDP, gawo lofunikira kwambiri pakuyambitsa njira, mwa kusintha zotsalira za cysteine za protein ya KRAS G12C molumikizana komanso mosasinthika. Kafukufuku wosankha cysteine wosatha adawonetsa kusankha kwakukulu kwa GFH925 ku G12C. Pambuyo pake, GFH925 imaletsa bwino njira yotsika ya chizindikiro kuti ipangitse maselo a chotupa kufooka komanso kuletsa kuzungulira kwa maselo.
Fulzerasib yalandiranso malangizo a Gulu 1 pa chithandizo cha KRAS G12C-mutant NSCLC m'malangizo a CSCO a 2025, kupatsa odwala njira yatsopano yothandizira yomwe ili ndi mphamvu yolimba komanso yolekerera bwino.
Malinga ndi deta ya gawo lachiwiri la kafukufuku wolembetsa pakati pa odwala omwe ali ndi KRAS G12C mutant NSCLC, chithandizo cha fulzerasib monotherapy chinapeza ORR ya 49.1% ndi PFS yapakati ya miyezi 9.7; chiŵerengero cha OS cha miyezi 12 chinali 54.4%, ndipo chiŵerengero cha DoR cha miyezi 12 chinali 53.7%. Chithandizo cha monotherapy chinapatsidwanso maudindo awiri a Breakthrough Therapy kuti athandize odwala a KRAS G12C-mutant NSCLC komanso odwala khansa ya m'matumbo.
Motsogozedwa ndi GenFleet mogwirizana ndi akatswiri apamwamba a khansa ya m'mapapo ku Europe, kafukufuku wa KROCUS wa fulzerasib pamodzi ndi cetuximab waperekanso mphamvu yodabwitsa kwa odwala onse oyamba a NSCLC komanso makamaka kuyankha kwapadera kwa chotupa pakati pa odwala omwe ali ndi khansa muubongo. Kuphatikiza apo, njira yogwiritsira ntchito mankhwalawa idawonetsa chitetezo/kulekerera bwino kuposa chithandizo cha fulzerasib mu chithandizo chachiwiri ndi chapamwamba cha NSCLC. Monga kuphatikiza koyamba kwa KRAS G12C inhibitor (fulzerasib) ndi anti-EGFR antibody (cetuximab) mu chithandizo cha khansa ya m'mapapo cha mzere woyamba, njira yatsopanoyi ili ndi kuthekera kokhazikitsa SOC ya m'badwo wotsatira ya chithandizo cha NSCLC cha mzere woyamba.
Malinga ndi zomwe zili mu chidule chomwe chinaperekedwa mochedwa pa msonkhano wapachaka wa European Lung Cancer Conference (ELCC) wa 2025, anthu 45 mwa omwe adatenga nawo mbali mu kafukufukuyu adalandira kafukufuku kamodzi kokha pambuyo pa chithandizo cha khansa kuyambira pa Januware 14 mu 2025: ORR idafika 80%; DCR idafika 100%; mPFS inali miyezi 12.5.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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Nthawi yotumizira: Julayi-15-2025