NMPA kwadoro Limertinib, ọgwụ EGFR nke ọgbọ nke atọ maka ọgwụgwọ mbụ nke kansa akpa ume

Na Eprel 25, 2025, Innovent Biologics kwupụtara na National Medical Products Administration (NMPA) nke China akwadola Ngwa Ọgwụ Ọhụrụ (NDA) maka limertinib dị ka ọgwụgwọ mbụ maka ndị toro eto nwere ọrịa kansa akpa ume nke na-abụghị obere mkpụrụ ndụ (NSCLC) nke nwere nhichapụ EGFR exon 19 ma ọ bụ mgbanwe exon 21 L858R.

Limertinib bụ ọgwụ EGFR TKI nke a na-enye site n'ọnụ, nke ọgbọ nke atọ, nke nwere ikike nkeonwe. NMPA nke China akwadola ya maka: 1) ọgwụgwọ ndị okenye nwere ọrịa kansa akpa ume EGFR T790M nke a na-akpọ "non-small cell lung cancer" (NSCLC), ndị nwere ọrịa ahụ n'oge ma ọ bụ mgbe a gwọchara ha na EGFR TKI; na 2) ọgwụgwọ mbụ nke ndị okenye nwere NSCLC nke a na-akpọ "metastatic" ma ọ bụ "metastatic" nke nwere NSCLC nke a na-akpọ "metastatic" ma ọ bụ "metastatic" nke nwere EGFR exon 19 ma ọ bụ mgbanwe exon 21 L858R.

Nkwanye ùgwù nke ihe ngosi ọhụrụ a sitere na nsonaazụ dị mma sitere na nnwale ahụike nke usoro nke atọ nke enweghị usoro, nke kpuru ìsì abụọ, nke egosipụtara na ọ dị mma. E debanyere aha ma nye ndị ọrịa 337 na-enweghị ọgwụgwọ na-enweghị isi na ọgwụgwọ nwere mgbanwe EGFR-positive mpaghara ma ọ bụ metastatic NSCLC 1:1 iji nweta limertinib ma ọ bụ gefitinib. Isi ihe dị mkpa bụ ndụ na-enweghị ọganihu (PFS), dịka kọmitii nyocha onwe onye (IRC) si nyochaa.

Data ahụ gosiri na limertinib dị ogologo oge karịa nke gefitinib (ọnwa 20.7 vs. ọnwa 9.7), nke na-anọchite anya mbelata ihe egwu nke 56% na ọganihu ọrịa ma ọ bụ ọnwụ (oke ihe egwu [HR] 0.44; 95% CI: 0.34–0.58; p < 0.0001). N'ime ndị ọrịa nwere mmerụ ahụ sistemụ akwara etiti (CNS) na mmalite, etiti CNS PFS dịkwa ogologo oge karịa na limertinib (ọnwa 20.7 vs. ọnwa 7.1), nke kwekọrọ na mbelata ihe egwu nke 72% maka ọganihu ma ọ bụ ọnwụ CNS (HR 0.28; 95% CI: 0.10–0.82; p = 0.0136), na-emesi ike ọrụ intracranial siri ike ya na uru ahụike ya na ndị bi na mkpa dị elu.

Nkọwa nchekwa nke limertinib kwekọrọ na nke ọgwụgwọ EGFR a ma ama. Ihe ndị na-adịghị mma bụ obere ruo na nke dị mfe ma dịkwa mma, enweghịkwa ihe mgbaàmà nchekwa ọhụrụ achọpụtara n'oge nnwale ahụike. A ga-ebipụta data na nyocha zuru oke site na ọmụmụ ihe a dị mkpa nke Usoro nke 3 na akwụkwọ akụkọ agụmakwụkwọ.

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