Nnabata nke Ngwa Ọgwụ Ọhụrụ maka ihe mgbochi pan-TRK Zurletrectinib na China

Na Eprel 15, 2025, InnoCare Pharma kwupụtara na Center for Drug Evaluation (CDE) nke China National Medical Products Administration (NMPA) nabatara Ngwa Ọgwụ Ọhụrụ (NDA) maka ọgbọ ọhụrụ ya nke pan-TRK inhibitor zurletrectinib (ICP-723) maka ọgwụgwọ nke ndị okenye na ndị nọ n'afọ iri na abụọ (afọ 12 ruo 18) nwere etuto siri ike dị elu nke nwere njikọ mkpụrụ ndụ ihe nketa NTRK.

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 ụmụaka, ọnụọgụ nke njikọta mkpụrụ ndụ ihe nketa NTRK karịrị 90%[1]. 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 na-anaghị egbo oke na mpaghara a n'ihi enweghị nhọrọ ọgwụgwọ dị irè.

Zurletrectinib bụ ọgwụ ọhụrụ nke ọgbọ ọhụrụ nke na-egbochi TRK nke gosipụtara ọrụ megide TRK WT na mutant kinases.

Akwụkwọ akụkọ British Journal of Cancer, nke bụ akụkụ nke akwụkwọ akụkọ sayensị kachasị elu nke Nature, bipụtara akwụkwọ akpọrọ "Zurletrectinib bụ ọgwụ mgbochi TRK nke ọgbọ na-abịa, nke nwere ọrụ siri ike n'ime cranial megide etuto ahụ NTRK fusion-positive, nke nwere ike iguzogide ihe ndị na-akpata ọgbọ mbụ". Akwụkwọ akụkọ ahụ kwubiri na zurletrectinib bụ ọgwụ mgbochi TRK ọhụrụ, nke nwere ike dị ukwuu, nke nwere ike ịbanye n'ime ụbụrụ dị elu ma nwee ike ime ka ọ dị ike karịa ndị ọzọ na-akpata ọgbọ na-abịa.

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.

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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