A ranar 12 ga Maris, 2025, Kamfanin Zai Lab Limited ya sanar da cewa Hukumar Kula da Kayayyakin Lafiya ta Kasa (NMPA) ta kasar Sin ta amince da Aikace-aikacen Lasisin Halittu (BLA) don TIVDAK (tisotumab vedotin-tftv) don maganin marasa lafiya da ke fama da cutar kansar mahaifa mai sake dawowa ko kuma ta yaɗuwa tare da ci gaban cututtuka a lokacin ko bayan jiyya ta yau da kullun.
An sami goyon bayan gabatarwar BLA daga sakamakon gwajin asibiti na duniya na innovaTV 301 na mataki na 3, wanda bazuwar tsari (NCT04697628) da kuma sakamakon da aka samu daga ƙaramin adadin jama'ar China na wannan binciken.
Jimillar marasa lafiya 502 sun yi gwajin bazuwar (an sanya 253 ga ƙungiyar tisotumab vedotin da 249 ga ƙungiyar chemotherapy); ƙungiyoyin sun yi kama da juna dangane da halayen alƙaluma da cututtuka. Matsakaicin rayuwa gabaɗaya ya fi tsayi a cikin ƙungiyar tisotumab vedotin fiye da ƙungiyar chemotherapy (watanni 11.5 [tazara amincewa 95% {CI}, 9.8 zuwa 14.9] idan aka kwatanta da watanni 9.5 [95% CI, 7.9 zuwa 10.7]), sakamakon da ya nuna ƙarancin haɗarin mutuwa da tisotumab vedotin fiye da tare da chemotherapy (rabowar haɗari, 0.70; 95% CI, 0.54 zuwa 0.89; P mai gefe biyu = 0.004). Matsakaicin rayuwa ba tare da ci gaba ba shine watanni 4.2 (95% CI, 4.0 zuwa 4.4) tare da tisotumab vedotin da watanni 2.9 (95% CI, 2.6 zuwa 3.1) tare da chemotherapy (rabowar haɗari, 0.67; 95% CI, 0.54 zuwa 0.82; P mai gefe biyu <0.001). Adadin amsawar da aka tabbatar shine 17.8% a cikin rukunin tisotumab vedotin da 5.2% a cikin rukunin chemotherapy (rabowar rashin daidaito, 4.0; 95% CI, 2.1 zuwa 7.6; P mai gefe biyu <0.001). Jimillar kashi 98.4% na marasa lafiya a cikin rukunin tisotumab vedotin da 99.2% a cikin rukunin chemotherapy sun sami aƙalla wani mummunan lamari wanda ya faru a lokacin jiyya (wanda aka ayyana a matsayin lokacin daga rana ta 1 na allurar 1 har zuwa kwanaki 30 bayan allurar ƙarshe); Abubuwan da suka faru a mataki na 3 ko sama da haka sun faru a kashi 52.0% da 62.3%, bi da bi. Jimillar kashi 14.8% na marasa lafiya sun daina maganin tisotumab vedotin saboda tasirin guba.
Game da TIVDAK (tisotumab vedotin-tftv)
TIVDAK (tisotumab vedotin) wani maganin rigakafi ne mai hade da kwayoyin halitta (ADC) wanda aka yi shi da kwayar halittar Genmab ta mutum wacce aka yi wa jagora zuwa ga sinadarin tissue factor (TF) da fasahar ADC ta Pfizer wacce ke amfani da hanyar haɗin protease-cleavable wanda ke haɗa sinadarin microtubule-disrupting agent monomethyl auristatin E (MMAE) zuwa ga antibody. Bayanan da ba na asibiti ba sun nuna cewa aikin anticancer na tisotumab vedotin ya samo asali ne daga ɗaurewar ADC da ƙwayoyin cutar kansa masu bayyana TF, sannan kuma shigar da hadaddun ADC-TF cikin jiki, da kuma sakin MMAE ta hanyar cire proteolytic. MMAE yana wargaza hanyar sadarwa ta microtubule na ƙwayoyin halitta masu rarrabawa, wanda ke haifar da kamawar zagayowar ƙwayoyin halitta da mutuwar ƙwayoyin apoptotic. A cikin vitro, tisotumab vedotin kuma yana daidaita phagocytosis na ƙwayoyin halitta masu dogara da antibody da kuma gubar ƙwayoyin halitta masu dogaro da antibody.
A halin yanzu, har yanzu akwai gwaje-gwaje da yawa na asibiti na sabbin fasahohin yaƙi da cutar kansa a China waɗanda ke neman marasa lafiya. Tuntuɓi kan sabbin magunguna da fasahohi, zaku iya tuntuɓar Sashen Ƙasa da Ƙasa na Asibitin Oncology na Yankin Kudu na Beijing.
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Email：myimmnet@163.com
Nassoshi
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.zailaboratory.com/
Lokacin Saƙo: Maris-14-2025