Na Eprel 25, 2025, InnoCare Pharma kwupụtara na Center for Drug Evaluation (CDE) nke China National Medical Products Administration (NMPA) enyela nyocha mbụ nke ọgbọ ọhụrụ ya nke pan-TRK inhibitor zurletrectinib (ICP-723), nke nabatara Ngwa Ọgwụ Ọhụrụ (NDA) nke zurletrectinib maka ọgwụgwọ nke ndị ọrịa nwere etuto siri ike siri ike nke nwere njikọ mkpụrụ ndụ ihe nketa NTRK n'oge na-adịbeghị anya. Nyocha mbụ bụ otu n'ime amụma ndị CDE webatara iji mee ka nkwenye ọgwụ dịkwuo ngwa ngwa.
N'ime nnwale ndebanye aha maka ndị ọrịa nwere etuto siri ike nke NTRK fusion-positive, zurletrectinib gosipụtara arụmọrụ pụrụ iche yana ezigbo profaịlụ nchekwa.
Dr. Jasmine Cui, onye hiwere InnoCare, onyeisi oche na onye isi oche, kwuru, sị, "Obi dị anyị ụtọ na enyerela zurletrectinib nyocha mbụ. Zurletrectinib egosila na ọ dị irè nke ukwuu ma nwee ezigbo nchekwa. Anyị na-atụ anya na ọ ga-enye nhọrọ ọgwụgwọ ka mma maka ndị ọrịa ruru eru nwere etuto siri ike na mbụ."
Zurletrectinib bụ ọgwụ mgbochi pan-TRK nke InnoCare mepụtara. Akwụkwọ akụkọ British Journal of Cancer, akụkụ nke akwụkwọ akụkọ sayensị kachasị elu Nature, bipụtara akwụkwọ akpọrọ "Zurletrectinib bụ ọgwụ mgbochi TRK nke ọgbọ na-esote nke nwere ọrụ siri ike n'ime cranial megide etuto ahụ NTRK fusion-positive nke nwere iguzogide ihe ndị na-akpata ọgbọ mbụ".
Akwụkwọ akụkọ ahụ kwuru na zurletrectinib gosipụtara ike siri ike megide kinases TRKA, TRKB, na TRKC WT, yana mgbanwe ndị a nwetara na TRKA G595R na TRKA G667C. Zurletrectinib dị ike karịa ndị FDA kwadoro ma ọ bụ ndị a nwalere n'ụlọ ọgwụ n'ọgbọ mbụ (larotrectinib) na ọgbọ na-esote (selitrectinib na repotrectinib) TRK ndị ọzọ megide ọtụtụ mgbanwe ndị na-egbochi TRK. N'otu aka ahụ, zurletrectinib (1 mg/kg BID) gbochiri uto etuto ahụ na ụdị xenograft sitere na mkpụrụ ndụ NTRK fusion-positive na dose ugboro 30 dị ala ma e jiri ya tụnyere selitrectinib.
Akwụkwọ ahụ gosikwara na, n'ọmụmụ ọgwụ pharmacokinetic nke sistemụ akwara etiti (CNS) na oke SD, zurletrectinib gosipụtara ikike ka mma ịbanye n'ime ihe mgbochi ọbara-ụbụrụ, na-erute ụbụrụ nke ọma karịa selitrectinib na repotrectinib. Mmụba nke Zurletrectinib n'ụbụrụ mekwara ka ọ bụrụ ọrụ mgbochi etuto ka mma. N'ihe nlereanya orthotopic glioma xenograft òké nwere mgbanwe iguzogide TRKA G598R/G670A, zurletrectinib (15 mg/kg) mere ka ndụ òké ndị nwere orthotopic NTRK fusion-positive, TRK-mutant gliomas ka mma nke ukwuu (ndụ etiti = 41.5, 66.5, na ụbọchị 104 maka selitrectinib, repotrectinib, na zurletrectinib n'otu n'otu; P < 0.05), na-egosi arụmọrụ ka mma ma e jiri ya tụnyere repotrectinib (15 mg/kg) na seletrectinib (30 mg/kg) (P=0.0384 na 0.0022, n'otu n'otu), yana profaịlụ nchekwa dị mma.
Mkpụrụ ndụ ihe nketa NTRK na-apụta n'ụdị dị iche iche nke etuto ndị toro eto na ụmụaka. N'ụfọdụ etuto ndị a na-adịghị ahụkebe, dịka kansa gland salivary, kansa ara secretory, na fibrosarcoma infantile, ọnụọgụ nke njikọta mkpụrụ ndụ ihe nketa NTRK karịrị 90%. A na-eme atụmatụ na enwere ihe dị ka ikpe ọhụrụ 6,500 nke etuto siri ike NTRK fusion-positive na China kwa afọ. Enwere mkpa ahụike dị ukwuu na-anaghị egbo mkpa n'akụkụ a n'ihi enweghị nhọrọ ọgwụgwọ dị irè.
Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.
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Oge ozi: Mee-07-2025