Musi wa10 Chikumi, Center for Drug Evaluation (CDE) yeNational Medical Products Administration (NMPA) yakazivisa kuti Trastuzumab Deruxtecan (T-DXd, DS-8201a) inokurudzirwa kuti iongororwe zvakanyanya pakurapa varwere vakuru vane HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma vakamborapwa kamwe chete kare.
Muongororo yeChikamu chechipiri cheDESTINY-Gastric01, DS-8201 yakavandudza zvakanyanya mwero wemhinduro uye kupona kwese kwese kwevarwere vane HER2-positive gastric adenocarcinoma (GC) kana gastroesophageal junction (GEJ) adenocarcinoma. Muongororo iyi yakanyoresa varwere 125 vakarapwa neDS-8201, zvichiratidza mwero wemhinduro chaiyo (ORR) we51%, nguva yemhinduro yepakati (DOR) yemwedzi 11.3, uye mwero wekutonga chirwere (DCR) we86%.
Chidzidzo chePhase III DESTINY-Gastric04 chakaongorora kushanda uye kuchengetedzeka kweTrastuzumab Deruxtecan (6.4 mg/kg) zvichienzaniswa neramucirumab pamwe nepaclitaxel senzira yechipiri yekurapa varwere vane HER2-positive isingabvisike uye/kana metastatic gastric kana GEJ adenocarcinoma. Zvakabuda zvakaratidza kuti, kubva muna Gumiguru 24, 2024, boka retrastuzumab deruxtecan rakaratidza kurarama kwenguva refu (OS) (mwedzi 14.7 zvichienzaniswa nemwedzi 11.4, HR=0.70, P=0.0044) uye kurarama pasina progression (PFS) (mwedzi 6.7 zvichienzaniswa nemwedzi 5.6). ORR yaive yakakwirawo (44.3% zvichienzaniswa ne29.1%), sezvakaita DCR (91.9% zvichienzaniswa ne75.9%).
Trastuzumab deruxtecan (yaimbonzi DS-8201), mushonga we antibody-drug conjugate une humanized anti-HER2 monoclonal antibody yakabatana ne topoisomerase I inhibitor payload kuburikidza ne tetrapeptide-based cleavable linker, yabvumidzwa kurapa varwere vane metastatic HER2-positive cancer. Kusiyana nedzimwe nzira dzakawanda dzakatenderwa dzeHER2-targeted, trastuzumab deruxtecan inogonawo kurwisa masero egomarara ane huwandu hwakaderera hweHER2 uye inogona kupa simba rayo re cytotoxic payload (drug-to-antibody ratio, 8:1) kuburikidza nemhedzisiro ye stander kune masero egomarara ari pedyo anoratidza HER2 zvakasiyana.
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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Nguva yekutumira: Chikumi-19-2025