Thaum Lub Plaub Hlis 15, 2025, InnoCare Pharma tshaj tawm tias Lub Chaw Saib Xyuas Kev Tshuaj Xyuas Tshuaj (CDE) ntawm Tuam Tshoj National Medical Products Administration (NMPA) tau txais Daim Ntawv Thov Tshuaj Tshiab (NDA) rau nws cov tshuaj tshiab pan-TRK inhibitor zurletrectinib (ICP-723) rau kev kho mob rau cov neeg laus thiab cov hluas (hnub nyoog 12 txog 18 xyoo) uas muaj cov qog nqaij hlav khov kho uas muaj NTRK gene fusions.
Cov noob caj noob ces NTRK tshwm sim hauv ntau hom qog nqaij hlav rau cov neeg laus thiab cov menyuam yaus. Hauv qee cov qog nqaij hlav tsis tshua muaj, xws li mob qog nqaij hlav salivary gland, mob qog nqaij hlav mis secretory, thiab infantile fibrosarcoma, qhov tshwm sim ntawm NTRK gene fusion tshaj 90%[1]. Kwv yees tias muaj kwv yees li 6,500 tus neeg mob tshiab ntawm NTRK fusion-positive solid tumors raug kuaj pom, hauv Suav teb txhua xyoo. Muaj cov kev xav tau kev kho mob tsis tau raws li qhov xav tau hauv thaj chaw no vim tsis muaj kev kho mob zoo.
Zurletrectinib yog ib qho tshuaj tshiab uas tsim tawm tshiab rau tiam tom ntej TRK inhibitor uas tau qhia txog kev ua haujlwm tawm tsam TRK WT thiab mutant kinases.
British Journal of Cancer, ib feem ntawm phau ntawv xov xwm tshawb fawb Nature, tau luam tawm ib daim ntawv hu ua "Zurletrectinib yog ib qho tshuaj TRK inhibitor tiam tom ntej nrog kev ua haujlwm intracranial muaj zog tiv thaiv NTRK fusion-positive qog nrog rau kev tiv thaiv rau thawj tiam neeg cov neeg sawv cev". Phau ntawv xov xwm xaus lus tias zurletrectinib yog ib qho tshiab, muaj zog heev TRK inhibitor tiam tom ntej nrog kev nkag mus rau hauv lub hlwb ntau dua thiab muaj zog dua intracranial dua li lwm cov neeg sawv cev tiam tom ntej.
Daim ntawv qhia tau hais tias zurletrectinib tau pom tias muaj zog tiv thaiv TRKA, TRKB, thiab TRKC WT kinases, nrog rau kev hloov pauv tiv thaiv TRKA G595R thiab TRKA G667C. Zurletrectinib muaj zog dua li lwm cov tshuaj TRK uas FDA pom zoo lossis tau kuaj hauv tsev kho mob thawj tiam (larotrectinib) thiab tiam tom ntej (selitrectinib thiab repotrectinib) tiv thaiv feem ntau cov kev hloov pauv tiv thaiv TRK inhibitor. Ib yam li ntawd, zurletrectinib (1 mg/kg BID) tau txwv tsis pub mob qog loj hlob hauv cov qauv xenograft uas tau los ntawm NTRK fusion-positive cells ntawm qhov koob tshuaj qis dua 30 npaug thaum piv rau selitrectinib.
Daim ntawv ntxiv tau qhia ntxiv tias, hauv kev tshawb fawb txog kev nkag mus rau hauv lub paj hlwb hauv nruab nrab (CNS) hauv cov nas SD, zurletrectinib tau qhia txog kev muaj peev xwm nkag mus rau hauv cov ntshav-lub hlwb thaiv, ncav cuag lub hlwb zoo dua li selitrectinib thiab repotrectinib. Zurletrectinib qhov kev nkag mus rau hauv lub hlwb ntau dua kuj tau txhais ua kev ua haujlwm tiv thaiv qog noj ntshav zoo dua. Hauv tus qauv orthotopic nas glioma xenograft uas muaj TRKA G598R/G670A tsis kam hloov pauv, zurletrectinib (15 mg/kg) tau txhim kho qhov muaj sia nyob ntawm cov nas uas muaj orthotopic NTRK fusion-positive, TRK-mutant gliomas (qhov muaj sia nyob nruab nrab = 41.5, 66.5, thiab 104 hnub rau selitrectinib, repotrectinib, thiab zurletrectinib feem; P < 0.05), qhia txog kev ua haujlwm zoo dua piv rau repotrectinib (15 mg/kg) thiab selitrectinib (30 mg/kg) (P=0.0384 thiab 0.0022, feem), nrog rau qhov profile kev nyab xeeb zoo heev.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
Xov Tooj: 4008803716
Email：myimmnet@163.com
Lub sijhawm tshaj tawm: Plaub Hlis-17-2025