Ku ya 12 Werurwe 2025, Zai Lab Limited yatangaje ko Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi mu Bushinwa (NMPA) cyemeye ubusabe bw’uruhushya rwa Biologics License (BLA) kuri TIVDAK (tisotumab vedotin-tftv) mu kuvura abarwayi barwaye kanseri y’inkondo y’umura isubira inyuma cyangwa yanduye ndetse n’indwara zikomeza kwiyongera mu gihe cy’ubuvuzi bw’umubiri cyangwa nyuma y’aho.
Ibyatanzwe na BLA bishyigikiwe n'ibyavuye mu igerageza rya muganga rya innovaTV 301 ku rwego rw'isi, ryakozwe ku buryo butaziguye, ku rwego rw'isi (Phase 3) (NCT04697628) n'ibyavuye mu bushinwa bw'abaturage bake muri ubu bushakashatsi.
Abarwayi 502 bose hamwe bakorewe ubushakashatsi ku buryo butaziguye (253 bashyizwe mu itsinda rya tisotumab vedotin na 249 mu itsinda rya chimiotherapie); ayo matsinda yari asa ugereranyije n'imiterere y'abaturage n'indwara. Impuzandengo y'ubuzima muri rusange yari igihe kirekire cyane mu itsinda rya tisotumab vedotin ugereranyije n'itsinda rya chimiotherapie (amezi 11.5 [95% igihe cy'icyizere {CI}, 9.8 kugeza 14.9] ugereranije n'amezi 9.5 [95% CI, 7.9 kugeza 10.7]), ibisubizo byagaragaje ko ibyago byo gupfa hakoreshejwe tisotumab vedotin biri hasi ho 30% ugereranyije n'imiti ya chimiotherapie (igipimo cy'ibyago, 0.70; 95% CI, 0.54 kugeza 0.89; P ifite impande ebyiri = 0.004). Impuzandengo y'ubuzima buzira ikwirakwira ry'imiti yari amezi 4.2 (95% CI, 4.0 kugeza 4.4) hamwe na tisotumab vedotin n'amezi 2.9 (95% CI, 2.6 kugeza 3.1) hamwe na chimiotherapie (igipimo cy'ibyago, 0.67; 95% CI, 0.54 kugeza 0.82; P <0.001 ifite impande ebyiri). Igipimo cy'ubutabazi bw'ibanze cyagaragajwe cyari 17.8% mu itsinda rya tisotumab vedotin na 5.2% mu itsinda rya chimiotherapie (igipimo cy'amahirwe, 4.0; 95% CI, 2.1 kugeza 7.6; P <0.001 ifite impande ebyiri). Abarwayi 98.4% mu itsinda rya tisotumab vedotin na 99.2% mu itsinda rya chimiotherapie bagize nibura ingaruka mbi imwe yabayeho mu gihe cyo kuvurwa (bisobanurwa nk'igihe kuva ku munsi wa mbere w'igipimo cya mbere kugeza ku minsi 30 nyuma y'igipimo cya nyuma); Ibyago byo mu cyiciro cya 3 cyangwa birenga byabaye kuri 52.0% na 62.3%, uko bikurikirana. 14.8% by'abarwayi bahagaritse imiti ya tisotumab vedotin kubera ingaruka z'uburozi.
Ku bijyanye na TIVDAK (tisotumab vedotin-tftv)
TIVDAK (tisotumab vedotin) ni antibody-drug conjugate (ADC) igizwe na antibody ya Genmab ya monoclonal y’umuntu yerekeza kuri tissue factor (TF) hamwe na ikoranabuhanga rya Pfizer rya ADC rikoresha protease-cleavable linker ihuza microtubule-disrupting agent monomethyl auristatin E (MMAE) na antibody. Amakuru atari ay’ubuvuzi agaragaza ko imikorere ya tisotumab vedotin yo kurwanya kanseri iterwa no gufatana kwa ADC n’uturemangingo twa kanseri twitwa TF, hagakurikiraho gushyira ADC-TF complex imbere, no kurekura MMAE binyuze mu gucika kwa proteolytic. MMAE ibangamira urusobe rwa microtubule rw’uturemangingo twitwa tubule, bigatera guhagarika cycle y’uturemangingo no gupfa kw’uturemangingo twa apoptotic. Muri vitro, tisotumab vedotin inafasha phagocytosis ya selile iterwa na antibody na cytotoxicity ya selile iterwa na antibody.
Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.
Nimero ya Terefone: 4008803716
Email：myimmnet@163.com
Amareferensi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.zailaboratory.com/
Igihe cyo kohereza: Werurwe-14-2025