Ma ʻApelila 25, 2025, ua hoʻolaha ʻo Innovent Biologics ua ʻāpono ka National Medical Products Administration (NMPA) o Kina i ka New Drug Application (NDA) no ka limertinib ma ke ʻano he lāʻau lapaʻau mua no nā poʻe maʻi makua me ka maʻi kanesa māmā non-small cell locally advanced a metastatic paha (NSCLC) me nā holoi ʻana o ka EGFR exon 19 a i ʻole nā mutation exon 21 L858R.
ʻO Limertinib kahi EGFR TKI hanauna ʻekolu i lawelawe waha ʻia me nā kuleana ponoʻī. Ua ʻāpono ʻia e ka NMPA o Kina no: 1) ka mālama ʻana i nā poʻe maʻi makua me ka maʻi kanesa māmā non-small cell EGFR T790M i hoʻololi ʻia i ka ʻāina holomua a i ʻole metastatic, ka poʻe i ʻike mua i ka holomua o ka maʻi i ka wā a ma hope paha o ka mālama ʻana me EGFR TKI; a me 2) ka mālama mua ʻana i nā poʻe maʻi makua me ka NSCLC i hoʻololi ʻia i ka ʻāina holomua a i ʻole metastatic e lawe ana i nā holoi ʻana o EGFR exon 19 a i ʻole nā mutation exon 21 L858R.
Ua kākoʻo ʻia ka ʻae ʻia ʻana o kēia hōʻailona hou e nā hopena maikaʻi mai kahi hoʻokolohua lapaʻau randomized, double-blind, positive-controlled Phase 3. Ua kākau inoa ʻia he 337 mau maʻi i loaʻa ʻole ka lāʻau lapaʻau me ka EGFR-sensitive mutation-positive locally advanced a metastatic NSCLC a i ʻole i hoʻokaʻawale ʻia 1:1 e loaʻa iā limertinib a i ʻole gefitinib. ʻO ke kumu nui o ka holomua ʻole o ke ola (PFS), e like me ka loiloi ʻana a ke kōmike loiloi kūʻokoʻa (IRC).
Ua hōʻike ʻia ka ʻikepili ua hoʻolōʻihi nui ka limertinib i ka median PFS i hoʻohālikelike ʻia me gefitinib (20.7 mahina vs. 9.7 mahina), e hōʻike ana i ka emi ʻana o ka pilikia he 56% i ka holomua ʻana o ka maʻi a i ʻole ka make (hazard ratio [HR] 0.44; 95% CI: 0.34–0.58; p < 0.0001). I nā poʻe maʻi me nā ʻeha o ka ʻōnaehana nerve waena (CNS) i ka wā mua, ua ʻoi aku ka lōʻihi o ka median CNS PFS me limertinib (20.7 mahina vs. 7.1 mahina), e like me ka emi ʻana o ka pilikia he 72% no ka holomua ʻana o ka CNS a i ʻole ka make (HR 0.28; 95% CI: 0.10–0.82; p = 0.0136), e hōʻike ana i kāna hana intracranial ikaika a me ka pono lapaʻau i loko o ia heluna kanaka me nā pono kiʻekiʻe i hoʻokō ʻole ʻia.
Ua kūlike ke ʻano palekana o limertinib me ko nā lāʻau lapaʻau i ʻike ʻia i kuhikuhi ʻia e EGFR. ʻO nā hanana ʻino he ʻoluʻolu a kaulike a ʻae maikaʻi ʻia, me ka ʻole o nā hōʻailona palekana hou i ʻike ʻia i ka wā o ka hoʻokolohua lapaʻau. E paʻi ʻia ka ʻikepili piha a me ka loiloi mai kēia haʻawina koʻikoʻi o ka Phase 3 ma nā puke pai kula.
I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.
Helu Kelepona：4008803716
Email：myimmnet@163.com
Ka manawa hoʻouna: Mei-07-2025