PLB1004 iyenera kuphatikizidwa mu chithandizo choyambira

PLB1004, yopangidwa ndi Beijing Avistone Biotechnology Co., Ltd., ndi mankhwala otetezeka, osankha bwino, komanso ogwira ntchito bwino otchedwa tyrosine kinase inhibitor (EGFR-TKI) omwe amagwiritsidwa ntchito pochiza khansa ya m'mapapo yopanda maselo ang'onoang'ono (NSCLC).

Pa Epulo 9, 2025, National Medical Products Administration Drug Evaluation Center (CDE) inasonyeza kuti PLB1004 ya Beijing Avistone Biotechnology inayenera kuphatikizidwa mu chithandizo chapamwamba cha odwala omwe ali ndi khansa ya m'mapapo ya maselo ang'onoang'ono (NSCLC) yomwe inali ndi kusintha kwa EGFR, yomwe inakula ndi/kapena kupitirira muyeso pambuyo poti chithandizo cha EGFR-TKI chalephera.

Zotsatira zoyambirira zachipatala za PLB1004 pamodzi ndi Vebreltinib pochiza odwala khansa ya m'mapapo omwe si ang'onoang'ono omwe ali ndi kusintha kwa EGFR, kukulitsa kwa MET kapena kuchuluka kwa MET pambuyo pa EGFR-TKI zidalengezedwa pa Msonkhano Wapadziko Lonse wa 2024 pa Khansa ya M'mapapo.

Odwala makumi anayi ndi anayi adalandira Vebreltinib 100mg kuphatikiza PLB1004 160mg (n=15), Vebreltinib 150mg kuphatikiza PLB1004 160mg (n=13), Vebreltinib 200mg kuphatikiza PLB1004 80mg (n=3), kapena Vebreltinib 150mg kuphatikiza PLB1004 80mg (n=13) ndipo adaphatikizidwa mu kusanthula konse kwa chitetezo. Pakati pa odwala 44 omwe adayesedwa, 36.4% ya odwala anali ndi metastases muubongo ndipo 86.4% ya odwala adalandira kale EGFR-TKI ya m'badwo wachitatu, motsatana. Mayankho olondola adachitika pamlingo wonse wa Vebreltinib ndi PLB1004 omwe adayesedwa, ndipo mayankho ochepa (PRs) adawonedwa mwa odwala 19/32 (59.4%) omwe adayesedwa. Pakati pa odwala omwe ali ndi metastases muubongo, ORR inali 75.0% (9/12). ORR inali 58.6% (17/29) mwa odwala omwe adalandira EGFR-TKI ya m'badwo wachitatu. Ma TRAE omwe amapezeka kwambiri anali ziphuphu ndi paronychia. Palibe odwala omwe adasiya kulandira chithandizo chifukwa cha TRAEs.

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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