Musi wa15 Kubvumbi, 2025, InnoCare Pharma yakazivisa kuti Center for Drug Evaluation (CDE) yeChina National Medical Products Administration (NMPA) yakagamuchira New Drug Application (NDA) yechizvarwa chayo chitsva chepan-TRK inhibitor zurletrectinib (ICP-723) yekurapa varwere vakuru nevachiri kuyaruka (makore gumi nemaviri kusvika gumi nemasere) vane bundu rakasimba rine NTRK gene fusions.
Majini eNTRK fusion anowanikwa mumhando dzakasiyana dzemabundu evakuru neevana. Mune mamwe mabundu asingawanzoitiki, akadai sesavary gland carcinoma, secretory breast cancer, uye infantile fibrosarcoma, kuwanda kweNTRK gene fusion kunodarika 90%[1]. Zvinofungidzirwa kuti kune nyaya itsva dzinosvika 6,500 dzemabundu eNTRK fusion-positive solid tumors dzinoonekwa, muChina gore rega rega. Kune zvinodiwa zvekiriniki zvisingawanikwe munzvimbo iyi nekuda kwekushaikwa kwenzira dzekurapa dzinoshanda.
Zurletrectinib mushonga mutsva weTRK wechizvarwa chinotevera wakagadzirwa munguva pfupi yapfuura waratidza kushanda pakurwisa TRK WT uye mutant kinases.
British Journal of Cancer, chikamu chemagazini yesainzi inotungamira Nature, yakaburitsa bepa rine musoro unoti "Zurletrectinib mushonga unodzivirira TRK wechizvarwa chinotevera une simba guru mukurwisa bundu reNTRK rinopinda mumusoro rine simba guru mukurwisa masero ekenza emudumbu ane simba guru muuropi". Magazini iyi yakagumisa kuti zurletrectinib mushonga mutsva, une simba guru muuropi hunotevera, une simba guru muuropi kupfuura mimwe mishonga yechizvarwa chinotevera.
Pepa iri rakaratidza kuti zurletrectinib yakaratidza simba guru pakurwisa TRKA, TRKB, uye TRKC WT kinases, pamwe nekuchinja kwe TRKA G595R uye TRKA G667C. Zurletrectinib yaishanda zvakanyanya kupfuura mamwe ma TRK inhibitors akatenderwa neFDA kana akaedzwa nekiriniki (larotrectinib) uye TRK inhibitors echizvarwa chinotevera (selitrectinib uye repotrectinib) achirwisa ma TRK inhibitors akawanda. Saizvozvowo, zurletrectinib (1 mg/kg BID) yakadzivirira kukura kwegomarara mu xenograft models dzinobva kumasero eNTRK fusion-positive pachiyero chakaderera ka30 kana zvichienzaniswa neselitrectinib.
Pepa iri rakaratidzawo kuti, muongororo yemishonga yepakati petsinga (CNS) mumakonzo eSD, zurletrectinib yakaratidza kugona kwakawedzerwa kupinda muropa-uropi, zvichisvika muuropi zvinobudirira kupfuura selitrectinib nerepotrectinib. Kuwedzera kwekupinda muuropi kweZurletrectinib kwakashandurwawo kuita basa rekudzivirira bundu. Mumuenzaniso we glioma xenograft yembeva ye orthotopic ine TRKA G598R/G670A resistance mutation, zurletrectinib (15 mg/kg) yakavandudza zvakanyanya kupona kwembeva dzine orthotopic NTRK fusion-positive, TRK-mutant gliomas (median survival = 41.5, 66.5, uye mazuva 104 e selitrectinib, repotrectinib, uye zurletrectinib zvichiteerana; P < 0.05), zvichiratidza kushanda zvakanaka zvichienzaniswa ne repotrectinib (15 mg/kg) uye selitrectinib (30 mg/kg) (P=0.0384 na 0.0022, zvichiteerana), ine hunhu hwakanaka hwekuchengetedza.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
Nhamba yefoni: 4008803716
Email：myimmnet@163.com
Nguva yekutumira: Kubvumbi-17-2025