I te 12 o Poutū-te-rangi, 2025, i panuitia e Zai Lab Limited kua whakaaetia e te Whakahaere Hua Hauora ā-Motu o Haina (NMPA) te Tono Raihana Koiora (BLA) mō te TIVDAK (tisotumab vedotin-tftv) hei rongoā mō ngā tūroro e pāngia ana e te mate pukupuku waha kōpū e hokihoki mai ana, e horapa ana rānei, me te whanaketanga o te mate i runga, i muri rānei i te rongoā pūnaha.
E tautokona ana te tukunga BLA e ngā hua mai i te whakamātautau haumanu ā-ao, matapōkeretia, Wāhanga 3 innovaTV 301 (NCT04697628) me ngā hua mai i te taupori iti o Haina o tēnei rangahau.
E 502 ngā tūroro i whakarōpūtia matapōkeretia (253 i tohaina ki te rōpū tisotumab vedotin, ā, 249 ki te rōpū chemotherapy); he rite tonu ngā rōpū e pā ana ki ngā āhuatanga taupori me te mate. He roa ake te oranga whānui toharite i roto i te rōpū tisotumab vedotin i te rōpū chemotherapy (11.5 marama [95% wā whakawhirinaki {CI}, 9.8 ki te 14.9] vs. 9.5 marama [95% CI, 7.9 ki te 10.7]), ko ngā hua i tohu i te 30% te iti iho o te mōrearea o te mate me te tisotumab vedotin i te chemotherapy (ōwehenga mōrearea, 0.70; 95% CI, 0.54 ki te 0.89; taha-rua P=0.004). Ko te roanga o te oranga kore-whakahaerenga ko te 4.2 marama (95% CI, 4.0 ki te 4.4) me te tisotumab vedotin me te 2.9 marama (95% CI, 2.6 ki te 3.1) me te chemotherapy (ōwehenga mōrearea, 0.67; 95% CI, 0.54 ki te 0.82; taha-rua P<0.001). Ko te reiti urupare whāinga kua whakaūtia ko te 17.8% i roto i te rōpū tisotumab vedotin me te 5.2% i roto i te rōpū chemotherapy (ōwehenga ōwehenga, 4.0; 95% CI, 2.1 ki te 7.6; taha-rua P<0.001). He 98.4% katoa o ngā tūroro i roto i te rōpū tisotumab vedotin me te 99.2% i roto i te rōpū chemotherapy i pāngia e te iti rawa kotahi te pānga kino i puta i te wā maimoatanga (i tautuhia ko te wā mai i te rā 1 o te horopeta 1 tae noa ki te 30 rā i muri i te horopeta whakamutunga); I puta ngā aituā taumata 3, neke atu rānei, i roto i te 52.0% me te 62.3%, ia. I mutu te maimoatanga tisotumab vedotin i te 14.8% katoa o ngā tūroro nā te mea he pānga paitini.
Mō TIVDAK (tisotumab vedotin-tftv)
Ko te TIVDAK (tisotumab vedotin) he hononga paturopi-rongoā (ADC) i hangaia mai i te paturopi monoclonal tangata a Genmab e arohia ana ki te kiko kiko (TF) me te hangarau ADC a Pfizer e whakamahi ana i te hononga protease-cleavable e hono tahi ana i te microtubule-disrupting agent monomethyl auristatin E (MMAE) ki te paturopi. E kī ana ngā raraunga kore-haumanu ko te mahi anti-matepukupuku o te tisotumab vedotin nā te herenga o te ADC ki ngā pūtau matepukupuku e whakaatu ana i te TF, ā, muri iho ka whakauruhia te matatini ADC-TF ki roto, me te tukunga o te MMAE mā te wehenga proteolytic. Ka whakararu te MMAE i te whatunga microtubule o ngā pūtau e wehewehe kaha ana, ka mutu te huringa pūtau me te mate pūtau apoptotic. I roto i te vitro, ka āwhina hoki te tisotumab vedotin i te phagocytosis pūtau e whakawhirinaki ana ki te paturopi me te cytotoxicity pūtau e whakawhirinaki ana ki te paturopi.
I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.
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Ngā Tohutoro
1.https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d
2.https://cn.zailaboratory.com/
Wā tuku: Maehe-14-2025