Te Whakaaetanga a te NMPA ki a Limertinib, he EGFR TKI o te whakatupuranga tuatoru mō te Maimoatanga Tuatahi o te Matepukupuku Pūkahukahu

I te 25 o Paenga-whāwhā, 2025, ka panuitia e Innovent Biologics kua whakaaetia e te Whakahaere Hua Hauora ā-Motu o Haina (NMPA) te Tono Rongoā Hou (NDA) mō te limertinib hei maimoatanga tuatahi mō ngā tūroro pakeke e pangia ana e te mate pukupuku pūkahukahu kore-pūtau iti (NSCLC) kua horapa ki te rohe, kua horapa rānei, e mau ana i ngā mukunga EGFR exon 19, i ngā whakarerekētanga exon 21 L858R rānei.

Ko Limertinib he rongoā EGFR TKI tuatoru-whakatipuranga e tukuna ana ki te waha, ā, he mana pupuri tōna. Kua whakaaetia e te NMPA o Haina mō: 1) te rongoā i ngā tūroro pakeke me te mate pukupuku pūkahukahu kore-pūtau iti (NSCLC) kua horapa ki te rohe, kua horapa rānei, kua pāngia e te mate i mua i te wā e rongoatia ana ki te EGFR TKI, i muri rānei i te rongoā; me te 2) te rongoā tuatahi mō ngā tūroro pakeke me te NSCLC kua horapa ki te rohe, kua horapa rānei, e mau ana i ngā mukunga EGFR exon 19, i ngā whakarerekētanga exon 21 L858R rānei.

Ko te whakaaetanga o tēnei tohu hou e tautokona ana e ngā hua pai mai i tētahi whakamātautau haumanu Wāhanga 3 matapōkere, matapo-rua, whakahaere-pai. E 337 ngā tūroro kāore anō kia whiwhi maimoatanga me te NSCLC kua horapa ā-rohe, kua pāngia rānei e te whakarerekētanga EGFR, i whakaurua, ā, i matapōkeretia i te 1:1 kia whiwhi i te limertinib, i te gefitinib rānei. Ko te mutunga matua ko te oranga kore-haere (PFS), i arotakehia e tētahi komiti arotake motuhake (IRC).

I whakaatuhia e ngā raraunga he nui te roa o te PFS waenga i te limertinib ki te whakataurite ki te gefitinib (20.7 marama vs. 9.7 marama), e tohu ana i te 56% te whakahekenga mōrearea o te whanaketanga o te mate, o te mate rānei (ōwehenga mōrearea [HR] 0.44; 95% CI: 0.34–0.58; p < 0.0001). I roto i ngā tūroro he whara o te pūnaha io matua (CNS) i te tīmatanga, he roa ake hoki te PFS waenga o te CNS me te limertinib (20.7 marama vs. 7.1 marama), e rite ana ki te 72% te whakahekenga mōrearea mō te whanaketanga o te CNS, te mate rānei (HR 0.28; 95% CI: 0.10–0.82; p = 0.0136), e whakaatu ana i tōna kaha o roto o te angaanga me te whai huatanga haumanu i roto i taua taupori he nui ngā matea kāore anō kia tutuki.

He rite tonu te haumaru o te limertinib ki ērā o ngā rongoā e mōhiotia ana mō te EGFR. Ko ngā pānga kino he ngawari ki te taurite, ā, he pai te manawanui, kāore he tohu haumaru hou i kitea i te wā o te whakamātautau haumanu. Ka whakaputaina ngā raraunga katoa me ngā tātaritanga mai i tēnei rangahau Wāhanga 3 nui ki roto i ngā puka mātauranga.

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.

Tau Waea：4008803716

Email：myimmnet@163.com