Na Machị 10, 2025, Sichuan Kelun-Biotech kwupụtara na National Medical Products Administration (NMPA) kwadoro ọgwụ trophoblast cell-surface antigen 2 (TROP2) nke ụlọ ọrụ ahụ na-eduzi antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, nke bụbu SKB264/MK-2870) maka ahịa maka ihe ngosi nke abụọ nke bụ maka ọgwụgwọ ndị ọrịa toro eto nwere epidermal growth factor receptor (EGFR) mutant-positive mpaghara advanced ma ọ bụ metastatic non-squamous non-squamous cell lung cancer (NSCLC) mgbe ọganihu na ọgwụgwọ EGFR-tyrosine kinase inhibitor (TKI) na chemotherapy dabere na platinum. Nke a bụ ọgwụ TROP2 ADC mbụ akwadoro maka ahịa na kansa akpa ume n'ụwa niile. Ma e jiri ya tụnyere ọkọlọtọ nlekọta ugbu a, sac-TMT na-ebelata uru ndụ nke ndị ọrịa a nke ukwuu.
Nkwado a dabere na nnyocha dị iche iche nke etiti, nke a na-achịkwaghị achịkwa, nke dị mkpa (OptiTROP-Lung03) nke na-enyocha irè na nchekwa nke sac-TMT monotherapy 5mg/kg kwa izu abụọ (Q2W) dị ka ọgwụ ntụtụ n'ime akwara ma ọ bụ docetaxel maka ọgwụgwọ nke ndị ọrịa nwere NSCLC EGFR-mutant nke dị elu ma ọ bụ metastatic nke mpaghara ma ọ bụ ndị dara ada mgbe ejiri ọgwụgwọ EGFR-TKI na ọgwụ dabere na platinum (eji ya n'usoro ma ọ bụ na njikọta). Dịka egosiri na nyocha oge akọwapụtara, sac-TMT monotherapy gosipụtara mmụba dị mkpa na nke bara uru na ọnụọgụgụ nzaghachi ebumnuche (ORR), nlanarị na-enweghị ọganihu (PFS) na nlanarị zuru oke (OS) ma e jiri ya tụnyere docetaxel.
Banyere sac-TMT
Sac-TMT bụ TROP2 ADC ọhụrụ nke ụlọ ọrụ ahụ nwere ikike ikike ọgụgụ isi nkeonwe, na-elekwasị anya na etuto siri ike dị elu dịka NSCLC, kansa ara (BC), kansa afọ (GC), etuto ụmụ nwanyị, na ndị ọzọ. E mepụtara Sac-TMT site na njikọ ọhụrụ iji jikọta ibu ibu ahụ, ihe mgbochi topoisomerase I nke belotecan-derivative nwere oke ọgwụ-na-antibody (DAR) nke 7.4. Sac-TMT na-amata TROP2 kpọmkwem n'elu mkpụrụ ndụ tumor site na recombinant anti-TROP2 humanized monoclonal antibody, nke mkpụrụ ndụ tumor na-etinye ma na-ewepụta KL610023 n'ime sel. KL610023, dị ka ihe mgbochi topoisomerase I, na-akpata mmebi DNA na mkpụrụ ndụ tumor, nke na-eduga na njide okirikiri sel na apoptosis. Na mgbakwunye, ọ na-ewepụtakwa KL610023 na gburugburu ebe obibi tumor. Ebe ọ bụ na KL610023 nwere ike ịbanye n'ime akpụkpọ ahụ, ọ nwere ike ime ka mmetụta nke onye na-ahụ ya n'anya, ma ọ bụ n'ikwu ya n'ụzọ ọzọ, gbuo mkpụrụ ndụ kansa ndị dị nso.
Na mbụ, NMPA akwadola ire ahịa sac-TMT na China maka ndị ọrịa toro eto nwere ọrịa kansa ara nke na-adịghị ahụkebe nke a na-apụghị ịgbanahụ n'ógbè ma ọ bụ nke na-adịghị mma nke nwere kansa ara atọ (TNBC) bụ ndị natara ma ọ dịkarịa ala ọgwụgwọ sistemụ abụọ gara aga (ma ọ dịkarịa ala otu n'ime ha maka ọnọdụ dị elu ma ọ bụ nke na-adịghị mma) ma nabatakwa ngwa ọgwụ ọhụrụ ọzọ (sNDA) na-achọ nkwado nke sac-TMT monotherapy maka ndị ọrịa nwere EGFR-mutant NSCLC ndị dara ada mgbe ọgwụgwọ EGFR-TKI gasịrị.
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: Maachị-20-2025