Kuvomerezedwa kwa Kugwiritsa Ntchito Mankhwala Atsopano a Pan-TRK Inhibitor Zurletrectinib ku China

Pa Epulo 15, 2025, InnoCare Pharma idalengeza kuti Center for Drug Evaluation (CDE) ya China National Medical Products Administration (NMPA) yavomereza New Drug Application (NDA) ya mbadwo watsopano wa pan-TRK inhibitor zurletrectinib (ICP-723) yochizira odwala akuluakulu ndi achinyamata (azaka 12 mpaka 18) omwe ali ndi zotupa zolimba zomwe zili ndi majini a NTRK.

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%[1]. Akuti pali milandu yatsopano pafupifupi 6,500 ya NTRK fusion-positive solid tumors yomwe imapezeka, ku China chaka chilichonse. Pali zosowa zachipatala zomwe sizikukwaniritsidwa m'derali chifukwa cha kusowa kwa njira zochizira zogwira mtima.

Zurletrectinib ndi mankhwala atsopano oletsa TRK omwe apangidwa posachedwapa omwe adawonetsa ntchito yolimbana ndi TRK WT ndi mutant kinases.

British Journal of Cancer, yomwe ndi gawo la magazini yotchuka ya sayansi ya Nature, inafalitsa nkhani yotchedwa "Zurletrectinib ndi mankhwala oletsa TRK a m'badwo wotsatira omwe ali ndi mphamvu yolimbana ndi zotupa za NTRK zomwe zimayambitsa fusion zomwe zimatsutsana ndi mankhwala a m'badwo woyamba". Magaziniyo inanena kuti zurletrectinib ndi mankhwala atsopano, amphamvu kwambiri a TRK a m'badwo wotsatira omwe ali ndi mphamvu yolowa mu ubongo m'thupi komanso mphamvu yogwira ntchito m'mutu kuposa mankhwala ena a m'badwo wotsatira.

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.

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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