Na June 30, ebe nrụọrụ weebụ gọọmentị nke National Medical Products Administration (NMPA) kwupụtara na Anlotinib, ọgwụ ọhụrụ Klas 1 nke Chia Tai Tianqing mepụtara, enwetala nkwado maka ihe ngosi ọhụrụ na China: ọgwụgwọ njikọta na chemotherapy maka ọgwụgwọ mbụ nke ndị ọrịa nwere sarcoma anụ ahụ dị nro nke na-enweghị ike iwepụ ma ọ bụ metastatic soft tissue sarcoma (STS) ndị na-enwetabeghị ọgwụgwọ sistemụ mbụ. Nke a bụ ihe ngosi nke itoolu akwadoro maka Anlotinib na China ma na-egosi nkwenye gọọmentị nke ọgwụgwọ njikọta chemotherapy mbụ n'ụwa maka ọgwụgwọ mbụ nke STS dị elu ma ọ bụ metastatic.
Anlotinib (AL3818, Anlotinib Hydrochloride) bụ ọgwụ ọhụrụ nke na-egbochi tyrosine kinase inhibitor (TKI) nke na-egbochi kinases dịka VEGFR, PDGFR, FGFR, na c-Kit nke ọma, na-enwe mmetụta mgbochi angiogenesis na-egbochi uto etuto ahụ.
Sarcoma anụ ahụ dị nro (STS) bụ ụdị ọrịa kansa nke sitere na anụ ahụ extraskeletal na-abụghị epithelial, yana ọnụego ihe dị ka 2.91 kwa 100,000 mmadụ na China, na-egosi mmụba kwa afọ [1-3]. STS gụnyere ụdị histological 19 na ihe karịrị ụdị ọrịa 50 dị iche iche. Ruo ọtụtụ iri afọ, chemotherapy dabere na anthracycline ejeela ozi dị ka ntọala nke ọgwụgwọ mbụ maka STS.
Na Nzukọ Kwa Afọ nke American Society of Clinical Oncology (ASCO) nke afọ 2025, ụlọ ọrụ ahụ gosipụtara ihe ịga nke ọma sitere na ọmụmụ ihe gbasara Phase III nke Anlotinib Hydrochloride Capsules yana chemotherapy maka ọgwụgwọ mbụ nke STS dị elu ma ọ bụ nke metastatic a na-apụghị ịgbanahụ.
Ụzọ: Ndị ruru eru enwetala ọgwụgwọ mbụ, ndị a kwadoro na ha nwere STS dị elu ma ọ bụ ndị na-anaghị ewepụ ọrịa ahụ. E tinyere ọgwụ ndị a n'ime usoro 1:1 iji nata ALTN (12mg) ọnụ otu ugboro kwa ụbọchị (izu abụọ na ezumike izu otu) tinyere EH (90 mg/m2) n'ime usoro 1:1 kwa izu atọ ruo oge 6, wee jiri ALTN (12mg) ọnụ otu ugboro kwa ụbọchị (izu abụọ na ezumike izu otu) ma ọ bụ PBO (0mg) ọnụ otu ugboro kwa ụbọchị (izu abụọ na ezumike izu otu) tinyere EH (90 mg/m2) n'ime usoro 1:1 kwa izu atọ ruo oge 6, wee jiri PBO (0mg) ọnụ otu ugboro kwa izu atọ ruo oge 6, wee jiri PBO (0mg) ọnụ otu ugboro kwa ụbọchị (izu abụọ na ezumike izu otu). E jiri PFS nyochaa isi ihe dị mkpa site na kọmitii nyocha onwe onye kpuru ìsì dịka RECIST 1.1 si kwuo. E jiri OS, ORR, Overage Response Rate (ORR), Overage Control Disease (DCR) na nchekwa.
Nsonaazụ: E tinyere ọnụọgụgụ 272 n'usoro: 135 ruo ogwe aka ALTN + EH, 137 ruo ogwe aka PBO + EH. Dịka ọ dị na Febụwarị 15, 2024, mgbe e mechara nyocha nke ọnwa 7.16, ogwe aka ALTN + EH ka mma nke ukwuu (HR 0.30 [95% CI 0.21-0.44]; P < 0.001; etiti 8.57 vs 3.02 mo), na ORR (17.8% vs 2.90%; P < 0.001), DCR (79.3% vs 54.7%; P < 0.001) megide ogwe aka PBO + EH. Erughị OS etiti ahụ n'aka abụọ ahụ (HR = 0.78 [95% CI: 0.49-1.25]). A hụrụ uru nke ogwe aka ALTN + EH n'ọtụtụ obere ndị a nwalere, gụnyere leiomyosarcoma, synovial sarcoma na ụdị ọrịa ndị ọzọ. Ọnọdụ nke ihe omume ọjọọ nke ọkwa ≥3 (AEs) (69.6% vs 59.1%), AEs nke butere ịkwụsị ọgwụgwọ (3.7% vs 4.4%), AEs ndị na-egbu egbu (3.7% vs 3.6%) yiri ibe ha n'etiti ogwe aka abụọ.
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: Julaị-01-2025