Ngomhla wama-25 ku-Epreli, ngo-2025, i-InnoCare Pharma ibhengeze ukuba isizukulwana sayo esitsha se-pan-TRK inhibitor zurletrectinib (ICP-723) sinikwe uphononongo oluphambili yiZiko loVavanyo lwaMayeza (CDE) le-China National Medical Products Administration (NMPA), elamkele isicelo esitsha se-zurletrectinib sokunyanga izigulane ezineethumba eziqinileyo ezigubungele i-NTRK gene fusions kutshanje. Uphononongo oluphambili ngomnye wemigaqo-nkqubo ephambili evezwe yi-CDE ukukhawulezisa ukuvunywa kwamayeza.
Kwilingo lokubhalisa izigulane ezine-NTRK fusion-positive solid tumors, i-zurletrectinib ibonakalise ukusebenza kakuhle kakhulu ngeprofayili yokhuseleko elungileyo.
UGqr. Jasmine Cui, umseki-mnye, usihlalo kunye ne-CEO ye-InnoCare, uthe, “Siyavuya kuba i-zurletrectinib inikwe uphononongo oluphambili. I-Zurletrectinib ibonakalise ukusebenza kakuhle kunye neprofayili yokhuseleko efanelekileyo. Silindele ukuba iya kubonelela ngeendlela zonyango ezingcono kwizigulana ezifanelekileyo ezineethumba eziqinileyo kwangethuba.”
I-Zurletrectinib sisithinteli se-pan-TRK esakhiwe yi-InnoCare. I-British Journal of Cancer, eyinxalenye yejenali yesayensi ehamba phambili i-Nature, ipapashe iphepha elinesihloko esithi “I-Zurletrectinib sisithinteli se-TRK sesizukulwana esilandelayo esinomsebenzi onamandla ngaphakathi kwentloko ngokuchasene neethumba ze-NTRK ezihambelana ne-fusion kunye nokumelana okujoliswe kuko kwiiarhente zesizukulwana sokuqala”.
Eli phepha libonise ukuba i-zurletrectinib ibonakalise amandla aqinileyo ngokuchasene ne-TRKA, TRKB, kunye ne-TRKC WT kinases, kunye nokuguqulwa kwe-TRKA G595R kunye ne-TRKA G667C. I-Zurletrectinib yayisebenza ngakumbi kunezinye izizukulwana zokuqala ezivunyiweyo yi-FDA okanye ezivavanyiweyo ngokwezonyango (i-larotrectinib) kunye nezizukulwana ezilandelayo (selitrectinib kunye ne-repotrectinib) TRK inhibitors ngokuchasene noninzi lwe-TRK inhibitors resistance mutations. Ngokufanayo, i-zurletrectinib (1 mg/kg BID) yathintela ukukhula kwethumba kwiimodeli ze-xenograft ezivela kwiiseli ze-NTRK fusion-positive kwidosi ephantsi ngokuphindwe ka-30 xa kuthelekiswa ne-selitrectinib.
Eli phepha libonise ngakumbi ukuba, kwisifundo se-CNS penetrant pharmacokinetic kwiimpuku ze-SD, i-zurletrectinib ibonakalise amandla aphuculweyo okungena kumqobo wegazi-ingqondo, ifikelela kwingqondo ngempumelelo ngakumbi kune-selitrectinib kunye ne-repotrectinib. Ukwanda kokungena kwengqondo kweZurletrectinib kuguqulelwe kumsebenzi ophuculweyo wokulwa nomhlaza. Kwimodeli ye-glioma xenograft yegundane le-orthotopic ephethe i-TRKA G598R/G670A resistance mutation, i-zurletrectinib (15 mg/kg) iphucule kakhulu ukusinda kweempuku ezine-orthotopic NTRK fusion-positive, TRK-mutant gliomas (ukusinda okuphakathi = 41.5, 66.5, kunye neentsuku ezili-104 ze-selitrectinib, repotrectinib, kunye ne-zurletrectinib ngokwahlukeneyo; P < 0.05), ebonisa ukusebenza kakuhle xa kuthelekiswa ne-repotrectinib (15 mg/kg) kunye ne-selitrectinib (30 mg/kg) (P=0.0384 kunye ne-0.0022, ngokwahlukeneyo), kunye neprofayili yokhuseleko egqwesileyo.
Iijini ze-NTRK fusion zenzeka kwiintlobo ezahlukeneyo zeethumba zabantu abadala kunye nabantwana. Kwezinye iithumba ezingaqhelekanga, ezifana ne-salivary gland carcinoma, umhlaza webele ofihlakeleyo, kunye ne-infantile fibrosarcoma, ukwenzeka kwe-NTRK gene fusion kudlula i-90%. Kuqikelelwa ukuba kukho malunga ne-6,500 iimeko ezintsha zeethumba eziqinileyo ze-NTRK fusion-positive ezifunyaniswa eTshayina minyaka le. Kukho iimfuno ezinkulu zeklinikhi ezingafezekiswanga kule ndawo ngenxa yokungabikho kweendlela zonyango ezisebenzayo.
Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.
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Ixesha leposi: Meyi-07-2025