Pa Ogasiti 29, mankhwala a Boehringer Ingelheim a HERNEXEOS® (mapiritsi a zongertinib) avomerezedwa ngati mankhwala amodzi okha ndi bungwe la National Medical Products Administration (NMPA) la ku China pochiza odwala akuluakulu omwe ali ndi khansa ya m'mapapo yopanda maselo ang'onoang'ono (NSCLC) yomwe singachiritsidwe, yomwe imayang'aniridwa bwino m'deralo kapena yomwe imafalikira m'malo enaake omwe ali ndi zotupa zomwe zimayambitsa kusintha kwa HER2 (ERBB2) ndipo omwe adalandira chithandizo chimodzi cham'mbuyomu.
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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Chivomerezo chokhazikika chaperekedwa kutengera deta yochokera ku mayeso a Phase Ib Beamion-LUNG 1 (NCT04886804): Mayeso otseguka, owonjezera mlingo wa Phase I, okhala ndi kutsimikizika kwa mlingo ndi kukulitsa, a zongertinib ngati chithandizo chimodzi mwa anthu omwe ali ndi zotupa zolimba zosasinthika kapena zofalikira ndi kusintha kwa HER2. Kafukufukuyu ali ndi magawo awiri. Gawo loyamba ndi lotseguka kwa akuluakulu omwe ali ndi mitundu yosiyanasiyana ya khansa yapamwamba yokhala ndi kusintha kwa HER2 komwe kumaphatikizapo kusintha kwa majini, kukulitsa, kuwonetsa mopitirira muyeso ndi kusakanikirana komwe chithandizo cham'mbuyomu sichinapambane. Gawo lachiwiri ndi lotseguka kwa anthu omwe ali ndi khansa ya m'mapapo ya HER2-mutant non-small cell.
Mu gulu loyamba, odwala 75 onse adalandira zongertinib pa mlingo wa 120 mg. Pa nthawi yowerengera deta (Novembala 29, 2024), 71% ya odwala awa (95% nthawi yodzidalira [CI], 60 mpaka 80; P<0.001 motsutsana ndi benchmark ya ≤30%) anali ndi yankho lotsimikizika; nthawi yapakati yoyankha inali miyezi 14.1 (95% CI, 6.9 mpaka yosayesedwa), ndipo kupulumuka kwapakati kopanda kupita patsogolo kunali miyezi 12.4 (95% CI, 8.2 mpaka yosayesedwa). Zochitika zoyipa zokhudzana ndi mankhwala a Giredi 3 kapena kupitirirapo zinachitika mwa odwala 13 (17%). Mu gulu la 5 (odwala 31), 48% ya odwala (95% CI, 32 mpaka 65) anali ndi yankho lotsimikizika lolondola. Zochitika zoyipa zokhudzana ndi mankhwala a Giredi 3 kapena kupitirirapo zinachitika mwa wodwala m'modzi (3%). Mu gulu lachitatu (odwala 20), 30% ya odwala (95% CI, 15 mpaka 52) adatsimikiziridwa kuti ali ndi yankho lolondola. Zotsatira zoyipa zokhudzana ndi mankhwala a Giredi 3 kapena kupitirira apo zidachitika mwa odwala 5 (25%). M'magulu onse atatu, palibe milandu ya matenda a m'mapapo okhudzana ndi mankhwala omwe adachitika.
"Ndizolimbikitsa kuona kuti NMPA ikuzindikirabe kuthekera kwa zongertinib. Kusankhidwa kwa njira yogwiritsira ntchito zongertinib koyamba ku China kukuwonetsa kufunikira kwachangu kwa odwala awa. Ndi gawo lotsatira lofunikira kwambiri kuti chithandizochi chipezeke kwa odwala ambiri omwe akufunika thandizo," adatero Shashank Deshpande, Wapampando wa Bungwe la Oyang'anira ku Boehringer Ingelheim.
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.
Nambala ya Foni: 4008803716
Chizindikiro cha WeChat: 17801183037
Email：myimmnet@163.com
Nthawi yotumizira: Sep-02-2025