Pa Epulo 25, 2025, InnoCare Pharma idalengeza kuti mbadwo watsopano wa pan-TRK inhibitor zurletrectinib (ICP-723) wapatsidwa mwayi wowunikiranso ndi Center for Drug Evaluation (CDE) ya China National Medical Products Administration (NMPA), yomwe idavomereza New Drug Application (NDA) ya zurletrectinib pochiza odwala omwe ali ndi zotupa zolimba zomwe zili ndi ma gene fusions a NTRK posachedwapa. Kuwunikanso koyambirira ndi imodzi mwa mfundo zazikulu zomwe CDE idakhazikitsa kuti ivomerezedwe ndi mankhwala mwachangu.
Mu kafukufuku wolembetsa odwala omwe ali ndi NTRK fusion-positive solid tumors, zurletrectinib adawonetsa kugwira ntchito bwino kwambiri ndi mbiri yabwino yotetezeka.
Dr. Jasmine Cui, yemwe anayambitsa, wapampando komanso CEO wa InnoCare, anati, "Tikusangalala kuti zurletrectinib yapatsidwa mwayi wowunikiranso. Zurletrectinib yawonetsa kuti imagwira ntchito bwino kwambiri komanso kuti ndi yotetezeka. Tikuyembekeza kuti ipereka chithandizo chabwino kwa odwala oyenerera omwe ali ndi zotupa zolimba kale."
Zurletrectinib ndi mankhwala oletsa pan-TRK omwe adapangidwa ndi InnoCare. British Journal of Cancer, yomwe ndi gawo la magazini yotchuka ya sayansi ya Nature, idasindikiza pepala lotchedwa "Zurletrectinib ndi mankhwala oletsa TRK a m'badwo wotsatira omwe ali ndi mphamvu yayikulu yolimbana ndi zotupa za NTRK zomwe zimatsutsana ndi mankhwala a m'badwo woyamba".
Pepalalo linanena kuti zurletrectinib inasonyeza mphamvu yolimbana ndi TRKA, TRKB, ndi TRKC WT kinases, komanso masinthidwe olimbana ndi TRKA G595R ndi TRKA G667C. Zurletrectinib inali yogwira ntchito kwambiri kuposa mibadwo ina yoyamba (larotrectinib) yovomerezedwa ndi FDA kapena yoyesedwa kuchipatala (selitrectinib) ndi mibadwo yotsatira (selitrectinib ndi repotrectinib) yolimbana ndi masinthidwe ambiri olimbana ndi TRK. Mofananamo, zurletrectinib (1 mg/kg BID) inaletsa kukula kwa chotupa m'mamodeli a xenograft ochokera ku maselo a NTRK fusion-positive pa mlingo wocheperako nthawi 30 poyerekeza ndi selitrectinib.
Pepalali linawonetsanso kuti, mu kafukufuku wa mankhwala okhudza dongosolo la mitsempha (CNS) mwa makoswe a SD, zurletrectinib inasonyeza luso lotha kulowa mu chotchinga cha magazi ndi ubongo, kufika mu ubongo bwino kwambiri kuposa selitrectinib ndi repotrectinib. Kuchuluka kwa kulowa mu ubongo kwa Zurletrectinib kunasinthidwanso kukhala ntchito yabwino yolimbana ndi chotupa. Mu chitsanzo cha mbewa ya orthotopic glioma xenograft yokhala ndi kusintha kwa TRKA G598R/G670A, zurletrectinib (15 mg/kg) idasintha kwambiri kupulumuka kwa mbewa zomwe zili ndi orthotopic NTRK fusion-positive, TRK-mutant gliomas (kupulumuka kwapakati = 41.5, 66.5, ndi masiku 104 a selitrectinib, repotrectinib, ndi zurletrectinib motsatana; P < 0.05), kuwonetsa kugwira ntchito bwino kwambiri poyerekeza ndi repotrectinib (15 mg/kg) ndi selitrectinib (30 mg/kg) (P=0.0384 ndi 0.0022, motsatana), ndi mbiri yabwino kwambiri yachitetezo.
Majini a NTRK fusion amapezeka m'mitundu yosiyanasiyana ya zotupa za akuluakulu ndi ana. Mu zotupa zina zosazolowereka, monga salivary gland carcinoma, secretory breast cancer, ndi infantile fibrosarcoma, kuchuluka kwa NTRK gene fusion kumaposa 90%. Akuti pali milandu yatsopano pafupifupi 6,500 ya NTRK fusion-positive solid tumors yomwe imapezeka ku China chaka chilichonse. Pali zosowa zazikulu zachipatala zomwe sizikukwaniritsidwa m'derali chifukwa cha kusowa kwa njira zochizira zogwira mtima.
Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.
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Nthawi yotumizira: Meyi-07-2025