PLB1004, nke Beijing Avistone Biotechnology Co., Ltd. mepụtara, bụ ihe nchekwa, nhọrọ dị oke elu, na nke na-adịghị agbanwe agbanwe nke na-arụ ọrụ nke ọma n'ịgwọ ọrịa kansa akpa ume na-abụghị obere mkpụrụ ndụ (NSCLC).
Na Eprel 9, 2025, National Medical Products Administration Drug Evaluation Center (CDE) gosiri na ebumnuche PLB1004 nke Beijing Avistone Biotechnology bụ itinye ya na ọgwụgwọ ọhụrụ maka ndị ọrịa nwere ọrịa kansa akpa ume nke dị elu n'ógbè ahụ ma ọ bụ METastatic non-small cell carcinoma (NSCLC) bụ ndị nwere mgbanwe EGFR, ndị nwetara mmụba na/ma ọ bụ oke mmetụta mgbe ọgwụgwọ EGFR-TKI dara ada.
E kwupụtara nsonaazụ mbụ nke PLB1004 yana Vebreltinib n'ọgwụgwọ nke ndị ọrịa kansa akpa ume na-abụghị obere sel nwere mgbanwe EGFR, mmụba MET ma ọ bụ oke MET mgbe EGFR-TKI gasịrị na Nzukọ Ụwa nke 2024 gbasara Ọrịa Kansa Akpa ume.
Ndị ọrịa iri anọ na anọ natara Vebreltinib 100mg gbakwunyere PLB1004 160mg (n=15), Vebreltinib 150mg gbakwunyere PLB1004 160mg (n=13), Vebreltinib 200mg gbakwunyere PLB1004 80mg (n=3), ma ọ bụ Vebreltinib 150mg gbakwunyere PLB1004 80mg (n=13) ma tinye ha na nyocha nchekwa zuru oke. N'ime ndị ọrịa iri anọ na anọ a nwalere, 36.4% nke ndị ọrịa nwere metastases ụbụrụ na 86.4% nke ndị ọrịa enwetalarị EGFR-TKI nke ọgbọ nke atọ, n'otu n'otu. Nzaghachi ebumnuche mere n'ofe ọkwa dose Vebreltinib na PLB1004 niile a nwalere, yana nzaghachi akụkụ (PRs) a hụrụ na ndị ọrịa 19/32 (59.4%) a na-enyocha nzaghachi. N'ime ndị ọrịa nwere metastases ụbụrụ, ORR bụ 75.0% (9/12). ORR dị pasent 58.6 (17/29) n'ime ndị ọrịa natara EGFR-TKI nke ọgbọ nke atọ tupu oge eruo. Ndị TRAE kachasị bụ ọnya na paronychia. Ọ dịghị onye ọrịa kwụsịrị ọgwụgwọ n'ihi TRAE.
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.
Nọmba ekwentị: 4008803716
Email：myimmnet@163.com
Oge ozi: Eprel-10-2025