Ukwamukelwa kwesicelo selayisensi ye-Biologics se-TIVDAK sokwelapha iziguli ezinomdlavuza wesibeletho ophindaphindayo noma osakazeka kalula

NgoMashi 12, 2025, i-Zai Lab Limited yamemezela ukuthi i-National Medical Products Administration (NMPA) yaseShayina yamukele Isicelo Selayisensi Ye-Biologics (BLA) se-TIVDAK (tisotumab vedotin-tftv) sokwelapha iziguli ezinomdlavuza wesibeletho ophindaphindayo noma osakazekile onezifo eziqhubekayo ngesikhathi noma ngemva kokwelashwa kwesistimu.

Ukuthunyelwa kwe-BLA kusekelwa yimiphumela evela esivivinyweni somtholampilo se-innovaTV 301 somhlaba wonke, esingahleliwe, (I-NCT04697628) kanye nemiphumela evela ekwandeni kwabantu baseShayina kulolu cwaningo.

Iziguli ezingu-502 zahlelwa ngokungahleliwe (253 zabelwa eqenjini le-vedotin le-tisotumab kanye nezingu-249 eqenjini le-chemotherapy); amaqembu ayefana maqondana nezici zabantu kanye nezifo. Ukusinda okumaphakathi kwakukude kakhulu eqenjini le-vedotin le-tisotumab kunaseqenjini le-chemotherapy (izinyanga ezingu-11.5 [95% isikhawu sokuzethemba {CI}, 9.8 kuya ku-14.9] uma kuqhathaniswa nezinyanga ezingu-9.5 [95% CI, 7.9 kuya ku-10.7]), imiphumela eyayimele ingozi ephansi ngo-30% yokufa nge-tisotumab vedotin kunange-chemotherapy (isilinganiso sengozi, 0.70; 95% CI, 0.54 kuya ku-0.89; izinhlangothi ezimbili P=0.004). Ukusinda okuphakathi nendawo okungenalo inqubekela phambili kwakuyizinyanga ezingu-4.2 (95% CI, 4.0 kuya ku-4.4) nge-tisotumab vedotin kanye nezinyanga ezingu-2.9 (95% CI, 2.6 kuya ku-3.1) nge-chemotherapy (isilinganiso sengozi, 0.67; 95% CI, 0.54 kuya ku-0.82; i-P-0.001 enezinhlangothi ezimbili). Izinga lokuphendula eliqinisekisiwe laliyi-17.8% eqenjini le-tisotumab vedotin kanye no-5.2% eqenjini le-chemotherapy (isilinganiso sezinkinga, 4.0; 95% CI, 2.1 kuya ku-7.6; i-P-0.001 enezinhlangothi ezimbili). Inani eliphelele lama-98.4% eziguli eqenjini le-tisotumab vedotin kanye no-99.2% eqenjini le-chemotherapy labane okungenani isenzakalo esisodwa esibi esenzeka ngesikhathi sokwelashwa (esichazwa njengesikhathi kusukela osukwini loku-1 lomthamo 1 kuya ezinsukwini ezingu-30 ngemva komthamo wokugcina); Izehlakalo zebanga lesi-3 noma ngaphezulu zenzeke ku-52.0% kanye no-62.3%, ngokulandelana. Ingqikithi yeziguli ezingu-14.8% zayeka ukwelashwa nge-tisotumab vedotin ngenxa yemiphumela enobuthi.

Mayelana ne-TIVDAK (tisotumab vedotin-tftv)

I-TIVDAK (i-tisotumab vedotin) iyi-antibody-drug conjugate (ADC) eyakhiwe yi-antibody ye-Genmab yomuntu eqondiswe ku-tissue factor (TF) kanye nobuchwepheshe be-Pfizer's ADC obusebenzisa i-protease-cleavable linker enamathisela ngokuhlanganyela i-microtubule-disrupting agent i-monomethyl auristatin E (MMAE) ku-antibody. Imininingwane engekho emitholampilo iphakamisa ukuthi umsebenzi we-tisotumab vedotin wokulwa nomdlavuza ubangelwa ukubopha kwe-ADC kumaseli omdlavuza aveza i-TF, kulandelwa ukufakwa ngaphakathi kwe-ADC-TF complex, kanye nokukhululwa kwe-MMAE nge-proteolytic cleavage. I-MMAE iphazamisa inethiwekhi ye-microtubule yamaseli ahlukanisayo, okuholela ekumisweni komjikelezo weseli kanye nokufa kweseli le-apoptotic. I-In vitro, i-tisotumab vedotin iphinde ilawule i-phagocytosis yeselula encike ku-antibody kanye ne-antibody-dependent cell cytotoxicity.

Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

Inombolo yocingo: 4008803716

Email：myimmnet@163.com

Izinkomba

1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

2.https://cn.zailaboratory.com/

3.I-Tisotumab Vedotin njengokwelashwa kwesibili noma kwesithathu komdlavuza wesibeletho ophindaphindayo | I-New England Journal of Medicine (nejm.org)