Ka la 15 Mmesa, 2025, InnoCare Pharma e phatlalalitse hore Setsi sa Tlhahlobo ea Lithethefatsi (CDE) sa Tsamaiso ea Lihlahisoa tsa Bongaka ea Naha ea Chaena (NMPA) se amohetse Kopo e Ncha ea Lithethefatsi (NDA) bakeng sa moloko oa sona o mocha oa pan-TRK inhibitor zurletrectinib (ICP-723) bakeng sa kalafo ea bakuli ba baholo le ba bacha (ba lilemo li 12 ho isa ho tse 18) ba nang le lihlahala tse tiileng tse tsoetseng pele tse nang le li-gene fusions tsa NTRK.
Lijini tsa NTRK fusion li hlaha mefuteng e fapaneng ea lihlahala tsa batho ba baholo le tsa bana. Lihlahalang tse ling tse sa tloaelehang, tse kang carcinoma ea litšoelesa tsa mathe, kankere ea matsoele e ntšang secretory, le fibrosarcoma ea masea, ketsahalo ea NTRK gene fusion e feta 90%[1]. Ho hakanngoa hore ho na le linyeoe tse ncha tse ka bang 6,500 tsa lihlahala tse tiileng tsa NTRK fusion-positive tse fumanoang, Chaena selemo se seng le se seng. Ho na le litlhoko tsa kliniki tse sa fihlelleheng haholo sebakeng sena ka lebaka la khaello ea mekhoa e sebetsang ea kalafo.
Zurletrectinib ke mothibi oa TRK oa moloko o latelang o sa tsoa qaptjoa o bontšitseng ts'ebetso khahlanong le TRK WT le li-kinase tse fetotsoeng.
British Journal of Cancer, e leng karolo ea koranta e etellang pele ea saense ea Nature, e phatlalalitse pampiri e nang le sehlooho se reng "Zurletrectinib ke thibelo ea TRK ea moloko o latelang e nang le ts'ebetso e matla ea kahare ho boko khahlanong le lihlahala tse nang le NTRK tse nang le khanyetso e tobileng ho li-agent tsa moloko oa pele". Koranta e fihletse qeto ea hore zurletrectinib ke thibelo e ncha, e matla haholo ea TRK ea moloko o latelang e nang le ho kenella ho hoholo ha boko ka har'a 'mele le ts'ebetso e matla ea kahare ho boko ho feta li-agent tse ling tsa moloko o latelang.
Pampiri e bontšitse hore zurletrectinib e bontšitse matla a maholo khahlanong le TRKA, TRKB, le TRKC WT kinases, hammoho le liphetoho tse fumanoeng tsa khanyetso ea TRKA G595R le TRKA G667C. Zurletrectinib e ne e le mafolofolo ho feta meloko e meng ea pele e amohetsoeng ke FDA kapa e lekiloeng ke lingaka (larotrectinib) le moloko o latelang (selitrectinib le repotrectinib) ea li-TRK inhibitors khahlanong le liphetoho tse ngata tsa khanyetso ea li-TRK inhibitors. Ka mokhoa o ts'oanang, zurletrectinib (1 mg/kg BID) e thibetse kholo ea hlahala mefuteng ea xenograft e nkiloeng liseleng tse nang le NTRK fusion-positive ka tekanyo e tlase ka makhetlo a 30 ha e bapisoa le selitrectinib.
Pampiri ena e boetse e bontšitse hore, thutong ea meriana ea tsamaiso ea methapo ea kutlo (CNS) e kenang litoebeng tsa SD, zurletrectinib e bontšitse bokhoni bo ntlafetseng ba ho kenella mokoallong oa mali le boko, e fihla bokong ka katleho ho feta selitrectinib le repotrectinib. Ho kenella ho eketsehileng ha boko ba Zurletrectinib ho ile ha boela ha fetoleloa tšebetsong e ntlafetseng ea ho loantša hlahala. Mohlaleng oa xenograft oa toeba ea orthotopic glioma o jereng phetoho ea khanyetso ea TRKA G598R/G670A, zurletrectinib (15 mg/kg) e ntlafalitse haholo ho phela ha litoeba tse nang le orthotopic NTRK fusion-positive, TRK-mutant gliomas (medium survival = 41.5, 66.5, le matsatsi a 104 bakeng sa selitrectinib, repotrectinib, le zurletrectinib ka ho latellana; P < 0.05), e bonts'ang katleho e phahameng ha e bapisoa le repotrectinib (15 mg/kg) le selitrectinib (30 mg/kg) (P=0.0384 le 0.0022, ka ho latellana), ka boemo bo botle ba polokeho.
Hona jwale, ho ntse ho na le diteko tse ngata tsa bongaka tsa mahlale a matjha a ho lwantsha kankere Chaena a batlang bakudi. Dipuisano mabapi le meriana le mahlale a matjha, o ka ikopanya le Lefapha la Matjhaba la Sepetlele sa Oncology sa Beijing Region South.
Nomoro ea mohala: 4008803716
Email：myimmnet@163.com
Nako ea poso: Mmesa-17-2025