Ma Malaki 12, 2025, ua hoʻolaha ʻo Zai Lab Limited ua ʻae ka National Medical Products Administration (NMPA) o Kina i ka Biologics License Application (BLA) no TIVDAK (tisotumab vedotin-tftv) no ka mālama ʻana i nā maʻi me ka maʻi ʻaʻai cervical e hana hou ana a metastatic paha me ka holomua o ka maʻi ma ka lāʻau lapaʻau systemic a ma hope paha.
Kākoʻo ʻia ka hoʻouna ʻana o BLA e nā hopena mai ka hoʻokolohua lapaʻau honua, randomized, Phase 3 innovaTV 301 (NCT04697628) a me nā hualoaʻa mai ka heluna kanaka Kina o kēia noiʻi.
He 502 mau maʻi i hana ʻia i ka randomization (253 i hoʻokaʻawale ʻia i ka hui tisotumab vedotin a me 249 i ka hui chemotherapy); ua like nā hui e pili ana i nā ʻano demographic a me nā maʻi. ʻOi aku ka lōʻihi o ke ola ʻana ma waena o ka hui tisotumab vedotin ma mua o ka hui chemotherapy (11.5 mau mahina [95% confidence interval {CI}, 9.8 a 14.9] vs. 9.5 mau mahina [95% CI, 7.9 a 10.7]), nā hopena i hōʻike i kahi 30% haʻahaʻa o ka make me ka tisotumab vedotin ma mua o ka chemotherapy (hazard ratio, 0.70; 95% CI, 0.54 a 0.89; ʻelua ʻaoʻao P = 0.004). ʻO ke ola waena me ka ʻole o ka holomua he 4.2 mau mahina (95% CI, 4.0 a 4.4) me ka tisotumab vedotin a me 2.9 mau mahina (95% CI, 2.6 a 3.1) me ka chemotherapy (lakio pōpilikia, 0.67; 95% CI, 0.54 a 0.82; ʻelua ʻaoʻao P<0.001). ʻO ka helu pane i hōʻoia ʻia he 17.8% i ka hui tisotumab vedotin a me 5.2% i ka hui chemotherapy (lakio odds, 4.0; 95% CI, 2.1 a 7.6; ʻelua ʻaoʻao P<0.001). ʻO ka huina o 98.4% o nā maʻi i ka hui tisotumab vedotin a me 99.2% i ka hui chemotherapy i loaʻa i hoʻokahi hanana maikaʻi ʻole i hana ʻia i ka wā mālama (i wehewehe ʻia ʻo ia ka manawa mai ka lā 1 o ka lāʻau 1 a hiki i 30 mau lā ma hope o ka lāʻau hope loa); Ua hana ʻia nā hanana papa 3 a ʻoi aku paha ma 52.0% a me 62.3%, kēlā me kēia. He 14.8% o nā maʻi i ho'ōki i ka mālama ʻana i ka tisotumab vedotin ma muli o nā hopena ʻawahia.
E pili ana iā TIVDAK (tisotumab vedotin-tftv)
ʻO TIVDAK (tisotumab vedotin) kahi antibody-drug conjugate (ADC) i haku ʻia me ka antibody monoclonal kanaka a Genmab i kuhikuhi ʻia i ka tissue factor (TF) a me ka ʻenehana ADC a Pfizer e hoʻohana ana i kahi linker protease-cleavable e hoʻopili covalently i ka microtubule-disrupting agent monomethyl auristatin E (MMAE) i ka antibody. Hōʻike nā ʻikepili nonclinical ʻo ka hana anticancer o tisotumab vedotin ma muli o ka nakinaki ʻana o ka ADC i nā TF-expressing cancer cells, ukali ʻia e ka internalization o ka ADC-TF complex, a me ka hoʻokuʻu ʻana o MMAE ma o ka proteolytic cleavage. Hoʻopilikia ka MMAE i ka pūnaewele microtubule o nā cell e māhele ikaika ana, e alakaʻi ana i ka hopu ʻana o ke kaʻina hana cell a me ka make ʻana o nā cell apoptotic. In vitro, hoʻoponopono pū ka tisotumab vedotin i ka antibody-dependent cellular phagocytosis a me ka antibody-dependent cellular cytotoxicity.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
Email：myimmnet@163.com
Nā Kuhikuhi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.zailaboratory.com/
Ka manawa hoʻouna: Malaki-14-2025