A natara nyocha mbụ maka ọrịa kansa afọ nke HER2-Positive na China maka Trastuzumab Deruxtecan

Na June 10, Center for Drug Evaluation (CDE) nke National Medical Products Administration (NMPA) kwupụtara na a na-atụ aro ka a nye Trastuzumab Deruxtecan (T-DXd, DS-8201a) nyocha mbụ maka ọgwụgwọ ndị okenye nwere ọrịa HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma nke dị n'ógbè ma ọ bụ nke metastatic, ndị natara otu usoro ọgwụgwọ mbụ.

N'ime nnwale nke Phase II DESTINY-Gastric01, DS-8201 mere ka ọnụego nzaghachi na ndụ zuru oke dịkwuo mma n'ime ndị ọrịa nwere HER2-positive gastric adenocarcinoma (GC) ma ọ bụ gastroesophageal junction (GEJ) adenocarcinoma. Nnwale ahụ debara aha ndị ọrịa 125 ejiri DS-8201 gwọọ, na-egosi ọnụego nzaghachi ebumnuche (ORR) nke 51%, oge nzaghachi etiti (DOR) nke ọnwa 11.3, na ọnụego njikwa ọrịa (DCR) nke 86%.

Nnyocha nke Phase III DESTINY-Gastric04 tụlere irè na nchekwa nke Trastuzumab Deruxtecan (6.4 mg/kg) ma e jiri ya tụnyere ramucirumab gbakwunyere paclitaxel dị ka ọgwụgwọ nke abụọ maka ndị ọrịa nwere HER2-positive unresectable na/ma ọ bụ metastatic gastric ma ọ bụ GEJ adenocarcinoma. Nsonaazụ gosiri na, dịka ọ dị na Ọktoba 24, 2024, otu trastuzumab deruxtecan gosipụtara ogologo ndụ zuru oke (OS) (ọnwa 14.7 vs. ọnwa 11.4, HR=0.70, P=0.0044) na ndụ na-enweghị ọganihu (PFS) (ọnwa 6.7 vs. ọnwa 5.6). ORR dịkwa elu (44.3% vs. 29.1%), dịka DCR si dị (91.9% vs. 75.9%).

Trastuzumab deruxtecan (nke bụbu DS-8201), ọgwụ mgbochi-ọgwụ jikọtara ya na ọgwụ mgbochi monoclonal nke a na-akpọ humanized anti-HER2 monoclonal nke ejikọtara ya na topoisomerase I inhibitor payload site na njikọ tetrapeptide nke a na-apụghị ịgbagha agbagha, ka akwadoro maka ọgwụgwọ ndị ọrịa nwere kansa ara HER2-positive metastatic. N'adịghị ka ọtụtụ ọgwụgwọ ndị ọzọ HER2 kwadoro, trastuzumab deruxtecan nwekwara ike ilekwasị anya na mkpụrụ ndụ kansa nke na-egosipụta obere ọkwa HER2 ma nwee ike ibuga ibu cytotoxic dị ike ya (nhazi ọgwụ-na-antibody, 8:1) site na mmetụta onye na-ekiri ya na mkpụrụ ndụ kansa ndị agbata obi na-egosipụta HER2 n'ụzọ dị iche iche.

Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.

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