Musi wa22 Chivabvu, 2025, Kelun Bio yakazivisa kuti chikumbiro chechiratidzo chitsva che trophoblast cell surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, inozivikanwawo seSKB264/MK – 2870) (®) chakagamuchirwa neCenter for Drug Evaluation (CDE) yeNational Medical Products Administration (NMPA) yeChina. Chiratidzo chitsva ichi ndechekurapa varwere vakuru vane kenza yemazamu isingabvisike kana kuti metastatic hormone receptor-positive (HR+) uye human epidermal growth factor receptor 2-negative (HER2-) (BC) avo vakagamuchira kare endocrine therapy nedzimwe nzira dzekurapa mu advanced kana metastatic setting. Kugamuchirwa uku kwakavakirwa pamhedzisiro yakanaka yekunyoresa Phase 3 OptiTROP – Breast02 study. Chikumbiro ichi ndicho chikumbiro chechina chechiratidzo che sac – TMT chakagamuchirwa neNMPA.
OptiTROP – Breast02 chidzidzo chekiriniki chePhase 3 chakaitwa nenzira isina kurongeka, yakavhurika, ine nzvimbo dzakawanda, chakaongorora kushanda uye kuchengetedzeka kwe sacituzumab tirumotecan monotherapy pachiyero che5 mg/kg mavhiki maviri ega ega (Q2W) zvichienzaniswa nesarudzo yachiremba ye chemotherapy muvarwere vane kenza yemazamu isingabvisike kana kuti metastatic HR+/HER2- (immunohistochemistry [IHC] 0, IHC 1+, kana IHC 2+/in situ hybridization [ISH]-). Zvichibva pakuongorora kwakatsanangurwa kare, chinangwa chikuru chekudzidza kwekiriniki kwePhase 3 chakawanikwa. Zvichienzaniswa nesarudzo yachiremba ye chemotherapy, sac – TMT monotherapy yakaratidza kuvandudzika kwakakosha uye kune revo mukurapa kwekutanga kwekusararama pasina progression (PFS) sezvakaongororwa ne blinded independent review committee (BIRC), nenjodzi yakaderera yekufambira mberi kwechirwere kana kufa. Sac – TMT yakaratidzawo mafambiro akanaka mukurarama kwese (OS).
Musi wa16 Chivabvu, 2024, webhusaiti yepamutemo yeCDE yakazivisa kuti Chikumbiro ichi chaizoongororwa kuburikidza nemaitiro ekuongorora nekubvumidza zvakakosha. Ichi chiratidzo chechina che sac-TMT chekuongorora nekubvumidza zvakakosha kweCDE, nezviratidzo zvitatu zvekare zve sat-TMT zvakabvumidzwa mushure mekuongorora kwekutanga.
About sac-TMT (佳泰莱®)
Sac-TMT, chigadzirwa chikuru cheKambani, iTROP2 ADC itsva yevanhu umo Kambani ine kodzero dzepfuma yepfungwa, inotarisa bundu rakasimba repamusoro senge kenza yemapapu isiri diki (NSCLC), BC, kenza yemudumbu (GC), bundu revakadzi, nezvimwewo. Sac-TMT yakagadzirwa nechinhu chitsva chinosanganisa mutoro wemushonga, inhibitor ye topoisomerase I inobva ku belotecan ine mushonga we antibody-ratio (DAR) we7.4. Sac-TMT inonyatsoona TROP2 pamusoro pemasero ebundu ne recombinant anti-TROP2 humanized monoclonal antibodies, iyo inobva yaiswa mumasero ebundu uye yaburitsa KL610023 mukati memasero. KL610023, semushonga we topoisomerase I, inokonzera kukuvara kweDNA kumasero ebundu, izvo zvinozokonzera kumisa kwemasero uye apoptosis. Pamusoro pezvo, inoburitsawo KL610023 munzvimbo yebundu. Zvichienderana nekuti KL610023 inopindirwa nemembrane, inogona kuita kuti pave nemhedzisiro yekutarisa, kana kuti nemamwe mazwi kuuraya masero egomarara ari pedyo.
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.
Nhamba yefoni: 4008803716
Email：myimmnet@163.com
Nguva yekutumira: Chivabvu-27-2025