I te 15 o Paenga-whāwhā, 2025, i panuitia e InnoCare Pharma kua whakaaetia e te Center for Drug Assessment (CDE) o te China National Medical Products Administration (NMPA) tētahi Tono Rongoā Hou (NDA) mō tana aukati pan-TRK whakatupuranga hou zurletrectinib (ICP-723) hei rongoā mō ngā tūroro pakeke me ngā taiohi (12 ki te 18 tau te pakeke) me ngā pukupuku totoka matatau e mau ana i ngā hononga ira NTRK.
Ka puta ngā ira whakakotahi NTRK i roto i ngā momo pukupuku pakeke me ngā tamariki. I roto i ētahi pukupuku onge, pērā i te carcinoma repe huware, te mate pukupuku ū huna, me te fibrosarcoma pēpi, neke atu i te 90% te auau o te whakakotahi ira NTRK [1]. E kiia ana kei te 6,500 ngā kēhi hou o ngā pukupuku totoka whakakotahi-pai NTRK ka kitea i Haina i ia tau. He tino kore e tutuki ngā hiahia haumanu i tēnei rohe nā te kore o ngā kōwhiringa maimoatanga whai hua.
Ko Zurletrectinib tētahi aukati TRK hou o te whakatipuranga hou i whakawhanakehia i ēnei rā tata nei, ā, i whakaatu i te kaha ki te whawhai ki te TRK WT me ngā mutant kinases.
I whakaputa te British Journal of Cancer, he wāhanga o te puka pūtaiao matua a Nature, i tētahi pepa ko "Zurletrectinib he aukati TRK o te whakatupuranga hou me te kaha o te mahi ā-roto o te angaanga ki ngā pukupuku NTRK fusion-positive me te ātete ki ngā kaihoko o te whakatupuranga tuatahi". I whakatau te puka ko te zurletrectinib he aukati TRK o te whakatupuranga hou, tino kaha, he nui ake te urunga ki te roro in vivo me te kaha ake o te mahi ā-roto o te angaanga i ētahi atu kaihoko o te whakatupuranga hou.
I roto i te pepa, i whakaatuhia e te zurletrectinib te kaha ki te whawhai ki ngā kinase TRKA, TRKB, me TRKC WT, tae atu ki ngā whakarerekētanga ātete TRKA G595R me TRKA G667C. He kaha ake te Zurletrectinib i ētahi atu aukati TRK whakatupuranga tuatahi (larotrectinib) me te whakatupuranga e whai ake nei (selitrectinib me repotrectinib) kua whakaaetia e te FDA, kua whakamatautauria rānei ki te haumanu, ki te whawhai ki te nuinga o ngā whakarerekētanga ātete aukati TRK. Waihoki, i aukati te zurletrectinib (1 mg/kg BID) i te tipu o te pukupuku i roto i ngā tauira xenograft i ahu mai i ngā pūtau NTRK fusion-positive i te horopeta 30 ngā wā iti iho i te wā e whakaritea ana ki te selitrectinib.
I whakaaturia anō e te pepa, i roto i tētahi rangahau pharmacokinetic penetrant pūnaha io matua (CNS) i roto i ngā kiore SD, i whakaatu te zurletrectinib i te kaha ake ki te uru atu ki te arai toto-roro, me te toro atu ki te roro he pai ake i te selitrectinib me te repotrectinib. Ko te pikinga o te urunga o Zurletrectinib ki te roro i whakamaoritia hoki hei whakapai ake i te mahi ārai pukupuku. I roto i tētahi tauira xenograft glioma kiore orthotopic e mau ana i te whakarerekētanga ātete TRKA G598R/G670A, i tino whakapai ake te zurletrectinib (15 mg/kg) i te oranga o ngā kiore e mau ana i ngā glioma NTRK fusion-positive, TRK-mutant (te oranga toharite = 41.5, 66.5, me te 104 rā mō te selitrectinib, repotrectinib, me te zurletrectinib; P < 0.05), e whakaatu ana i te whai huatanga pai ake ki te repotrectinib (15 mg/kg) me te selitrectinib (30 mg/kg) (P=0.0384 me te 0.0022, ia), me te kōtaha haumaru tino pai.
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.
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Wā tuku: 17 Paenga-whāwhā 2025