Ma Ianuali 16, 2025, ua ʻāpono ka National Medical Products Administration (NMPA) o Kina i ka New Drug Application (NDA) o limertinib no ka mālama ʻana i nā poʻe maʻi makua me ka maʻi kanesa māmā non-small cell EGFR T790M-mutated locally advanced or metastatic (NSCLC).
E pili ana iā Limertinib
ʻO Limertinib kahi EGFR TKI hanauna ʻekolu i lawelawe waha ʻia me nā kuleana ponoʻī, i ʻāpono ʻia e ka NMPA o Kina no ka mālama ʻana i nā poʻe maʻi makua me ka maʻi kanesa māmā non-small cell EGFR T790M i hoʻololi ʻia ma kahi kūloko a i ʻole metastatic (NSCLC). Aia ka lua o ka NDA ma lalo o ka loiloi NMPA no ka mālama mua ʻana i nā poʻe maʻi makua me ka NSCLC i hoʻololi ʻia ma kahi kūloko a i ʻole metastatic e lawe ana i nā holoi ʻana o EGFR exon 19 a i ʻole nā mutation exon 21 L858R.
Ua hōʻike ka lāʻau lapaʻau i ka holomua ma kahi hoʻokolohua lapaʻau Phase 3 multi-center, randomized, double-blind, controlled Phase 3 e hoʻohālikelike ana i kona pono a me ka palekana o gefitinib i ka lāʻau lapaʻau mua o nā maʻi me ka NSCLC holomua kūloko a metastatic paha e hūnā ana i nā hoʻololi EGFR. Me ka hoʻokō ʻia ʻana o ka hopena mua, e hōʻike ʻia nā hopena ma nā ʻaha kūkā kula e hiki mai ana a i ʻole e paʻi ʻia ma nā puke pai kula.
Ua kākoʻo ʻia ka hoʻoholo hoʻoponopono e ka ʻikepili mai kahi hoʻokolohua koʻikoʻi pae 2b (NCT03502850), He haʻawina lima hoʻokahi kēia, hāmama-lepili, pae 2b i mālama ʻia ma 62 mau haukapila ma ka Repubalika o Kina. Ua kākau inoa ʻia nā maʻi me ka NSCLC holomua kūloko a metastatic paha me nā mutations EGFR T790M i hōʻoia ʻia ma ke kikowaena i loko o ka ʻiʻo tumor a i ʻole ka plasma koko i holomua ma hope o nā mea hoʻopaʻa mua a ʻelua paha o ka hanauna EGFR tyrosine kinase a i ʻole me nā mutations EGFR T790M mua.
Mai Iulai 16, 2019, a hiki i Malaki 10, 2021, ua kākau inoa ʻia he 301 mau maʻi a hoʻomaka i ka mālama ʻana me limertinib. Ua komo nā maʻi āpau i ka hoʻonohonoho loiloi piha a me ka hoʻonohonoho palekana. Ma ka lā palena ʻikepili ma Kepakemapa 9, 2021, ua noho ʻo 76 (25.2%) ma ka mālama ʻana. ʻO ka manawa hahai waena he 10.4 mau mahina. Ma ke kumu o ka hoʻonohonoho loiloi piha, ʻo ka ORR i loiloi ʻia e ke kōmike loiloi kūʻokoʻa he 68.8% a ʻo ka helu kaohi maʻi he 92.4%. ʻO ka PFS waena he 11.0 mau mahina, ʻo ka DoR waena he 11.1 mau mahina, a ʻaʻole i hiki i ka OS waena. Ua hoʻokō ʻia nā pane pahuhopu ma nā hui liʻiliʻi i kuhikuhi mua ʻia. No 99 mau maʻi (32.9%) me nā metastases o ka ʻōnaehana nerve waena (CNS), ʻo ka ORR he 64.6%, ʻo ka PFS waena he 9.7 mau mahina (95% CI: 5.9–11.6), a ʻo ka DoR waena he 9.6 mau mahina. No 41 mau maʻi i loaʻa ka lesion CNS hiki ke loiloi ʻia, ʻo ka CNS-ORR i hōʻoia ʻia he 56.1% a ʻo ka CNS-PFS waena he 10.6 mau mahina.
Ma ka hoʻonohonoho palekana, ua loaʻa i nā maʻi he 289 (96.0%) ma ka liʻiliʻi hoʻokahi hanana ʻino e pili ana i ka lāʻau lapaʻau (TRAE), me ka mea maʻamau ka maʻi diarrhea (81.7%), anemia (32.6%), ʻulaʻula (29.9%), a me anorexia (28.2%). Ua loaʻa nā TRAE Papa ≥3 i 104 mau maʻi (34.6%), me ka mea maʻamau me ka diarrhea (13.0%), hypokalemia (4.3%), anemia (4.0%), a me ka ʻulaʻula (3.3%). Ua loaʻa nā TRAE e alakaʻi ana i ka hoʻopau ʻana i ka lāʻau a me ka hoʻopau ʻana i ka lāʻau i 24.6% a me 2% o nā maʻi, kēlā me kēia. ʻAʻohe TRAE i alakaʻi i ka make.
Nā hopena
Ua ʻike ʻia he hopena maikaʻi ko Limertinib (ASK120067) a me kahi ʻano palekana i ʻae ʻia no ka mālama ʻana i nā maʻi me ka NSCLC EGFR T790M-mutated kūloko a i ʻole metastatic.
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.
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Nā Kuhikuhi
2.ʻO Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) (ask-pharm.com)
4.https://www.jto.org/article/S1556-0864(22)00267-2/fulltext
Ka manawa hoʻouna: Ian-21-2025