Pa 12 Marichi, 2025, Zai Lab Limited idalengeza kuti bungwe la National Medical Products Administration (NMPA) la ku China lavomereza Fomu Yofunsira Chilolezo cha Biologics (BLA) ya TIVDAK (tisotumab vedotin-tftv) yochizira odwala omwe ali ndi khansa ya pachibelekero yomwe imabwereranso kapena yofalikira kwambiri komanso matenda omwe akupita patsogolo panthawi ya chithandizo chamankhwala kapena atangomaliza.
Kuperekedwa kwa BLA kumathandizidwa ndi zotsatira za mayeso azachipatala apadziko lonse lapansi, osasankhidwa, a innovaTV 301 Phase 3 (NCT04697628) ndi zotsatira kuchokera ku chiwerengero cha anthu aku China cha kafukufukuyu.
Odwala onse 502 adachitidwa mwachisawawa (253 adapatsidwa gulu la tisotumab vedotin ndi 249 adapatsidwa gulu la chemotherapy); maguluwo anali ofanana pankhani ya kuchuluka kwa anthu ndi matenda. Kupulumuka kwapakati kunali kwakutali kwambiri mu gulu la tisotumab vedotin kuposa gulu la chemotherapy (miyezi 11.5 [95% nthawi yodzidalira {CI}, 9.8 mpaka 14.9] poyerekeza ndi miyezi 9.5 [95% CI, 7.9 mpaka 10.7]), zotsatira zake zomwe zidawonetsa chiopsezo chotsika cha imfa ndi 30% ndi tisotumab vedotin kuposa ndi chemotherapy (chiŵerengero cha zoopsa, 0.70; 95% CI, 0.54 mpaka 0.89; two-sided P=0.004). Kupulumuka kwapakati popanda kupita patsogolo kunali miyezi 4.2 (95% CI, 4.0 mpaka 4.4) ndi tisotumab vedotin ndi miyezi 2.9 (95% CI, 2.6 mpaka 3.1) ndi chemotherapy (chiŵerengero cha zoopsa, 0.67; 95% CI, 0.54 mpaka 0.82; P <0.001 yokhala ndi mbali ziwiri). Chiŵerengero chotsimikizika cha yankho lolondola chinali 17.8% mu gulu la tisotumab vedotin ndi 5.2% mu gulu la chemotherapy (chiŵerengero cha mwayi, 4.0; 95% CI, 2.1 mpaka 7.6; P <0.001 yokhala ndi mbali ziwiri). Odwala onse 98.4% mu gulu la tisotumab vedotin ndi 99.2% mu gulu la chemotherapy anali ndi vuto limodzi losachepera lomwe linachitika panthawi ya chithandizo (lomwe limatanthauzidwa kuti nthawi kuyambira tsiku loyamba la mlingo woyamba mpaka masiku 30 pambuyo pa mlingo womaliza); Zochitika za giredi 3 kapena kuposerapo zinachitika mu 52.0% ndi 62.3%, motsatana. Odwala onse okwana 14.8% anasiya kulandira chithandizo cha tisotumab vedotin chifukwa cha zotsatirapo zake zoopsa.
About TIVDAK (tisotumab vedotin-tftv)
TIVDAK (tisotumab vedotin) ndi mankhwala ophatikizana ndi ma antibody (ADC) opangidwa ndi ma antibody a Genmab omwe amayendetsedwa ku tissue factor (TF) ndi ukadaulo wa Pfizer's ADC womwe umagwiritsa ntchito cholumikizira cholumikizira cha protease chomwe chimalumikiza microtubule-disrupting agent monomethyl auristatin E (MMAE) ku antibody. Deta yosakhala yachipatala imasonyeza kuti ntchito yolimbana ndi khansa ya tisotumab vedotin imachitika chifukwa cha kumangirira kwa ADC ku maselo a khansa omwe amawonetsa TF, kutsatiridwa ndi kulowetsedwa kwa ADC-TF complex, ndikutulutsidwa kwa MMAE kudzera mu proteolytic cleavage. MMAE imasokoneza netiweki ya microtubule ya maselo omwe amagawa mwachangu, zomwe zimapangitsa kuti cell cycle isamagwire ntchito komanso kufa kwa apoptotic cell. Mu vitro, tisotumab vedotin imathandizanso kuti ma cell a antibody-dependent cellular phagocytosis ndi antibody-dependent cellular cytotoxicity.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
Nambala ya Foni: 4008803716
Email：myimmnet@163.com
Zolemba
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.zailaboratory.com/
Nthawi yotumizira: Marichi-14-2025