Ma ʻApelila 25, 2025, ua hoʻolaha ʻo InnoCare Pharma ua hāʻawi ʻia kāna hanauna hou pan-TRK inhibitor zurletrectinib (ICP-723) i ka loiloi koʻikoʻi e ke Center for Drug Evaluation (CDE) o ka China National Medical Products Administration (NMPA), nāna i ʻae i ka New Drug Application (NDA) o zurletrectinib no ka mālama ʻana i nā maʻi me nā ʻōpū paʻa holomua e hūnā ana i nā hui gene NTRK i hala koke nei. ʻO ka loiloi koʻikoʻi kekahi o nā kulekele koʻikoʻi i hoʻolauna ʻia e ka CDE e hoʻolalelale i ka ʻae ʻia ʻana o ka lāʻau.
Ma ka hoʻokolohua hoʻopaʻa inoa no nā maʻi me nā puʻupuʻu paʻa NTRK fusion-positive, ua hōʻike ʻo zurletrectinib i ka pono koʻikoʻi me kahi ʻaoʻao palekana maikaʻi.
Ua ʻōlelo ʻo Kauka Jasmine Cui, ka mea nāna i hoʻokumu pū, luna hoʻomalu a me Luna Nui o InnoCare, "Ua hauʻoli mākou ua hāʻawi ʻia ka loiloi koʻikoʻi iā zurletrectinib. Ua hōʻike ʻo Zurletrectinib i ka pono koʻikoʻi a me kahi ʻano palekana maikaʻi. Manaʻo mākou e hāʻawi ia i nā koho lapaʻau maikaʻi aʻe no nā poʻe maʻi kūpono me nā puʻupuʻu paʻa ma mua."
ʻO Zurletrectinib kahi mea hoʻopaʻa pan-TRK i hoʻomohala ʻia e InnoCare. Ua paʻi ʻo British Journal of Cancer, kahi 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 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.
Loaʻa nā genes fusion NTRK i nā ʻano ʻōpū makua a me nā keiki like ʻole. I loko o kekahi mau tumors 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%. Ua manaʻo ʻia aia ma kahi o 6,500 mau hihia hou o nā tumors paʻa NTRK fusion-positive i ʻike ʻia ma Kina i kēlā me kēia makahiki. Aia nā pono lapaʻau koʻikoʻi i hoʻokō ʻole ʻia ma kēia wahi ma muli o ka nele o nā koho lapaʻau kūpono.
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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Ka manawa hoʻouna: Mei-07-2025