Kuwunika Kwambiri kwa Trastuzumab Deruxtecan ku China kwa Khansa Yam'mimba Yabwino Kwambiri ya HER2

Pa June 10, Center for Drug Evaluation (CDE) ya National Medical Products Administration (NMPA) inalengeza kuti Trastuzumab Deruxtecan (T-DXd, DS-8201a) ikuperekedwa kuti iwunikidwenso bwino pochiza odwala akuluakulu omwe ali ndi HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma omwe adalandirapo chithandizo chimodzi kale.

Mu kafukufuku wa Gawo Lachiwiri la DESTINY-Gastric01, DS-8201 inakweza kwambiri kuchuluka kwa mayankho ndi kupulumuka kwa odwala omwe ali ndi HER2-positive gastric adenocarcinoma (GC) kapena gastroesophageal junction (GEJ) adenocarcinoma. Kafukufukuyu adalembetsa odwala 125 omwe adalandira chithandizo cha DS-8201, kuwonetsa kuchuluka kwa mayankho olondola (ORR) kwa 51%, nthawi yapakati yoyankha (DOR) ya miyezi 11.3, ndi kuchuluka kwa matenda (DCR) kwa 86%.

Kafukufuku wa Gawo Lachitatu la DESTINY-Gastric04 adawunika momwe Trastuzumab Deruxtecan (6.4 mg/kg) imagwirira ntchito poyerekeza ndi ramucirumab pamodzi ndi paclitaxel ngati chithandizo chachiwiri kwa odwala omwe ali ndi HER2-positive osachira komanso/kapena matenda a m'mimba omwe amafalikira kapena GEJ adenocarcinoma. Zotsatira zake zidawonetsa kuti, kuyambira pa Okutobala 24, 2024, gulu la trastuzumab deruxtecan lidawonetsa kupulumuka kwanthawi yayitali (OS) (miyezi 14.7 poyerekeza ndi miyezi 11.4, HR=0.70, P=0.0044) komanso kupulumuka kosapitirira muyeso (PFS) (miyezi 6.7 poyerekeza ndi miyezi 5.6). ORR inalinso yokwera (44.3% poyerekeza ndi 29.1%), monga momwe zinalili ndi DCR (91.9% poyerekeza ndi 75.9%).

Trastuzumab deruxtecan (yomwe kale inali DS-8201), cholumikizira cha antibody-drug chokhala ndi antibody ya HER2 monoclonal yolumikizidwa ndi topoisomerase I inhibitor payload kudzera mu tetrapeptide-based cleavable linker, chavomerezedwa kuti chichiritse odwala omwe ali ndi khansa ya m'mawere ya HER2-positive. Mosiyana ndi mankhwala ena ambiri ovomerezeka a HER2, trastuzumab deruxtecan imathanso kulimbana ndi maselo a chotupa omwe amawonetsa milingo yotsika ya HER2 ndipo imatha kupereka mphamvu yake yamphamvu ya cytotoxic payload (mankhwala-kwa-antibody ratio, 8:1) kudzera mu zotsatira za stander ku maselo oyandikana nawo a chotupa omwe akuwonetsa HER2 mosiyana.

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

Email：myimmnet@163.com