Ma ʻApelila 15, 2025, ua hoʻolaha ʻo InnoCare Pharma ua ʻae ke Kikowaena no ka Loiloi Lāʻau Lapaʻau (CDE) o ka China National Medical Products Administration (NMPA) i kahi Noi Lāʻau Lapaʻau Hou (NDA) no kāna hanauna hou pan-TRK inhibitor zurletrectinib (ICP-723) no ka mālama ʻana i nā maʻi pākeke a me nā ʻōpio (12 a 18 mau makahiki) me nā ʻōpū paʻa holomua e hūnā ana i nā hui gene NTRK.
Loaʻa nā genes fusion NTRK i nā ʻano ʻano puʻupuʻu pākeke a me nā keiki. I loko o kekahi mau puʻupuʻu kakaikahi, e like me ka salivary gland carcinoma, ka maʻi ʻaʻai umauma secretory, a me ka fibrosarcoma pēpē, ʻoi aku ka nui o ka fusion gene NTRK ma mua o 90% [1]. Ua manaʻo ʻia aia ma kahi o 6,500 mau hihia hou o nā puʻupuʻu paʻa NTRK fusion-positive i ʻike ʻia, ma Kina i kēlā me kēia makahiki. Nui nā pono lapaʻau i hoʻokō ʻole ʻia ma kēia wahi ma muli o ka nele o nā koho lapaʻau kūpono.
ʻO Zurletrectinib kahi mea hoʻopaʻa TRK hanauna hou i hoʻomohala hou ʻia i hōʻike i ka hana kūʻē i ka TRK WT a me nā mutant kinases.
Ua paʻi ka British Journal of Cancer, he ʻāpana o ka puke pai ʻepekema koʻikoʻi ʻo Nature, i kahi pepa i kapa ʻia ʻo "Zurletrectinib kahi mea hoʻopaʻa TRK hanauna hou me ka hana intracranial ikaika e kūʻē i nā tumors fusion-positive NTRK me ke kū'ē ʻana ma ka pahuhopu i nā mea hana hanauna mua". Ua hoʻoholo ka puke pai he mea hoʻopaʻa TRK hanauna hou a ikaika loa ka zurletrectinib me ke komo ʻana o ka lolo in vivo kiʻekiʻe a me ka hana intracranial ikaika ma mua o nā mea hana hanauna hou ʻē aʻe.
Ua kuhikuhi ka pepa ua hōʻike ʻo zurletrectinib i ka ikaika ikaika e kūʻē iā TRKA, TRKB, a me TRKC WT kinases, a me nā mutations pale i loaʻa iā TRKA G595R a me TRKA G667C. ʻOi aku ka ikaika o Zurletrectinib ma mua o nā hanauna mua ʻē aʻe i ʻae ʻia e ka FDA a i hoʻāʻo ʻia e ke kauka (larotrectinib) a me ka hanauna hou (selitrectinib a me repotrectinib) TRK inhibitors e kūʻē i ka hapa nui o nā mutations pale pale TRK. Pēlā nō, ua kāohi ʻo zurletrectinib (1 mg/kg BID) i ka ulu ʻana o ka puʻupuʻu i nā hiʻohiʻona xenograft i loaʻa mai nā cell NTRK fusion-positive ma kahi mahele he 30 mau manawa haʻahaʻa i ka hoʻohālikelike ʻia me selitrectinib.
Ua hōʻike hou aku ka pepa, ma kahi noiʻi pharmacokinetic penetrant o ka ʻōnaehana nerve waena (CNS) i nā ʻiole SD, ua hōʻike ʻo zurletrectinib i ka hiki ke komo i loko o ka pale koko-lolo, e hiki ai i ka lolo me ka ʻoi aku ka maikaʻi ma mua o selitrectinib a me repotrectinib. Ua unuhi ʻia hoʻi ka hoʻonui ʻia ʻana o ka komo ʻana o ka lolo o Zurletrectinib i ka hana antitumor i hoʻomaikaʻi ʻia. I loko o kahi kumu hoʻohālike xenograft glioma ʻiole orthotopic e lawe ana i ka mutation kū'ē TRKA G598R/G670A, ua hoʻomaikaʻi nui ʻo zurletrectinib (15 mg/kg) i ke ola ʻana o nā ʻiole e hūnā ana i nā orthotopic NTRK fusion-positive, TRK-mutant gliomas (median survival = 41.5, 66.5, a me 104 mau lā no selitrectinib, repotrectinib, a me zurletrectinib; P < 0.05), e hōʻike ana i ka pono kiʻekiʻe i hoʻohālikelike ʻia me repotrectinib (15 mg/kg) a me selitrectinib (30 mg/kg) (P=0.0384 a me 0.0022, kēlā me kēia), me kahi ʻaoʻao palekana maikaʻi loa.
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: ʻApelila-17-2025