Musi wa12 Kurume, 2025, Zai Lab Limited yakazivisa kuti National Medical Products Administration (NMPA) yeChina yakagamuchira Biologics License Application (BLA) yeTIVDAK (tisotumab vedotin-tftv) yekurapa varwere vane kenza yemumuromo inodzoka kana kuti yakapararira nechirwere ichi mushure mekurapwa kwemuviri.
Kuendeswa kweBLA kunotsigirwa nemhedzisiro yekuyedzwa kwekiriniki kwepasi rose, kwakasarudzika, kwePhase 3 innovaTV 301 (NCT04697628) uye zvakabuda muhuwandu hwevanhu vekuChina muongororo iyi.
Varwere vanosvika mazana mashanu nevaviri vakaitwa randomized (253 vakaiswa muboka retisotumab vedotin uye 249 vakaiswa muboka retisotumab chemotherapy); mapoka acho akafanana maererano nehuwandu hwevanhu uye hunhu hwezvirwere. Kurarama kwepakati kwaive kwenguva yakareba zvakanyanya muboka retisotumab vedotin pane muboka retisotumab (mwedzi 11.5 [95% confidence interval {CI}, 9.8 kusvika 14.9] vs. mwedzi 9.5 [95% CI, 7.9 kusvika 10.7]), mhedzisiro yacho yakaratidza mukana wakaderera we30% wekufa netisotumab vedotin pane netisotumab chemotherapy (hazard ratio, 0.70; 95% CI, 0.54 kusvika 0.89; two-sided P=0.004). Kurarama kwepakati pasina kufambira mberi kwaive kwemwedzi 4.2 (95% CI, 4.0 kusvika 4.4) netisotumab vedotin uye mwedzi 2.9 (95% CI, 2.6 kusvika 3.1) nechemotherapy (hazard ratio, 0.67; 95% CI, 0.54 kusvika 0.82; two-sided P<0.001). Chiyero chemhinduro chakasimbiswa chaive 17.8% muboka retisotumab vedotin uye 5.2% muboka rechemotherapy (odds ratio, 4.0; 95% CI, 2.1 kusvika 7.6; two-sided P<0.001). Huwandu hwe98.4% yevarwere muboka retisotumab vedotin uye 99.2% muboka rechemotherapy vaive nechiitiko chimwe chete chakaipa chakaitika panguva yekurapwa (chinotsanangurwa senguva kubva pazuva rekutanga redosi 1 kusvika mazuva makumi matatu mushure medosi yekupedzisira); Zviitiko zvegiredhi rechitatu kana kupfuura zvakaitika mu52.0% uye 62.3%, zvichiteerana. Huwandu hwe14.8% yevarwere vakarega kurapwa netisotumab vedotin nekuda kwemigumisiro ine chepfu.
Nezve TIVDAK (tisotumab vedotin-tftv)
TIVDAK (tisotumab vedotin) iantibody-drug conjugate (ADC) inoumbwa neGenmab's human monoclonal antibody inotungamirwa ku tissue factor (TF) uye Pfizer's ADC technology inoshandisa protease-cleavable linker iyo inobatanidza microtubule-disrupting agent monomethyl auristatin E (MMAE) kune antibody. Ruzivo rusiri rwekiriniki runoratidza kuti basa rekurwisa kenza retisotumab vedotin rinokonzerwa nekusunga kweADC kumasero ekenza anoburitsa TF, zvichiteverwa nekuisa mukati meADC-TF complex, uye kuburitswa kweMMAE kuburikidza neproteolytic cleavage. MMAE inokanganisa network ye microtubule yemasero anoparadzanisa, zvichikonzera kumisa kwemasero uye kufa kwemasero eapoptotic. In vitro, tisotumab vedotin inodzorawo antibody-dependent cellular phagocytosis uye antibody-dependent cellular cytotoxicity.
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
Mareferensi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.zailaboratory.com/
Nguva yekutumira: Kurume-14-2025