Na June 30, 2025, HUTCHMED kwupụtara na China National Medical Products Administration (NMPA) enyela ikike maka ojiji ọgwụ ọhụrụ (NDA) maka njikọta nke ORPATHYS (savolitinib) na TAGRISSO (osimertinib) maka ọgwụgwọ ndị ọrịa nwere ọrịa kansa akpa ume nke na-adịghị ahụkebe ma ọ bụ nke na-adịghị ahụkebe (EGFR) nke na-abụghị nke obere mkpụrụ ndụ (NSCLC) na mmụba MET mgbe ọrịa gasịrị na ọgwụgwọ EGFR tyrosine kinase inhibitor (TKI). ORPATHYS bụ ọgwụ MET TKI nke a na-aṅụ n'ọnụ, nke dị ike ma na-ahọrọ nke ukwuu. TAGRISSO bụ ọgwụ EGFR TKI nke ọgbọ nke atọ, nke a na-apụghị ịgbanwe agbanwe.
ORPATHYS bụ ọgwụ mgbochi MET mbụ a họọrọ nke akwadoro na China, nke enyere maka ndị ọrịa toro eto nwere NSCLC dị elu ma ọ bụ metastatic nwere mgbanwe MET exon 14. Nkwenye ọhụrụ a nke NMPA dabere na data sitere na nnwale SACHI Phase III nke njikọta ORPATHYS na TAGRISSO (NCT05015608), ebe o zutere njedebe mbụ nke ndụ na-enweghị ọganihu (PFS) nke akọwapụtara tupu oge eruo na nyocha nwa oge emere atụmatụ ya. E gosipụtara nsonaazụ mbụ na Nzukọ Kwa Afọ nke American Society of Clinical Oncology (ASCO) na June 2025.
Dịka e si depụta data nyocha nwa oge nke Ọgọst 30, 2024, e kewapụrụ ọnụọgụ ndị ọrịa 211 iji nweta njikọta savolitinib na osimertinib ma ọ bụ chemotherapy. N'ebumnobi ịgwọ ndị mmadụ (ITT), ndụ nke onye nyocha nyochara enweghị ọganihu (PFS) bụ ọnwa 8.2 site na iji savolitinib na osimertinib, ma e jiri ya tụnyere ọnwa 4.5 site na iji chemotherapy. Kọmitii nyocha nke onwe (IRC) nyochachara ọnụọgụ PFS dị n'etiti bụ ọnwa 7.2 megide ọnwa 4.2, n'otu n'otu.
Ọnụọgụ nzaghachi ebumnuche (ORR) nke onye nyocha nyochara bụ 58% na otu savolitinib plus osimertinib ma e jiri ya tụnyere 34% maka ndị ọrịa nọ na otu chemotherapy. Ọnụọgụ njikwa ọrịa (DCR) bụ 89% vs 67% na etiti oge nzaghachi (DoR) bụ ọnwa 8.4 vs ọnwa 3.2, n'otu n'otu. N'ozuzu, ndụ ezughị oke n'oge nyocha nwa oge.
Nsonaazụ arụmọrụ nke ndị ọrịa EGFR tyrosine kinase inhibitor (TKI) nke ọgbọ nke atọ jiri tụnyere ndị nọ n'ọgbọ nke atọ nke EGFR-TKI na-enweghị uche. N'ọgbọ nke atọ nke ọgbọ nke atọ nke EGFR-TKI na-agwọ, PFS nke onye nyocha nyochachara na nke IRC na-enyocha dị nnọọ iche, ma na ọnwa 6.9 vs 3.0.
A na-anabata nchekwa nke njikọta savolitinib na osimertinib, a hụghịkwa ihe mgbaàmà nchekwa ọhụrụ. Ihe omume ọjọọ nke ọgwụgwọ nke ọkwa 3 ma ọ bụ karịa mere na 57% nke ndị ọrịa nọ na otu savolitinib na osimertinib ma e jiri ya tụnyere 57% maka ndị ọrịa nọ na otu chemotherapy, nke na-egosi na ọ dị mma maka nchekwa.
Banyere ORPATHYS
ORPATHYS (savolitinib) bụ ọgwụ MET TKI nke a na-eji ọnụ, nke nwere ike, nke a na-ahọpụta nke ukwuu nke egosila ọrụ ahụike na etuto siri ike dị elu. Ọ na-egbochi mmegharị a na-ahụkarị nke ụzọ MET receptor tyrosine kinase nke na-eme n'ihi mgbanwe (dịka mgbanwe exon 14 na-awụlikwa elu ma ọ bụ mgbanwe isi ndị ọzọ), mmụba mkpụrụ ndụ ihe nketa ma ọ bụ oke mmepụta protein.®
Banyere TAGRISSO®
TAGRISSO (osimertinib) bụ ọgbọ nke atọ, nke a na-agbanweghi agbanwe, nke nwere ọrụ ahụike a nwapụtara na NSCLC, gụnyere megide metastases nke sistemụ akwara etiti (CNS). Ejirila TAGRISSO (mkpụrụ ọgwụ 40mg na 80mg otu ugboro kwa ụbọchị) gwọọ ihe fọrọ nke nta ka ọ bụrụ ndị ọrịa 800,000 n'ofe ihe mgbaàmà ya n'ụwa niile, AstraZeneca na-aga n'ihu na-enyocha TAGRISSO dị ka ọgwụgwọ maka ndị ọrịa n'ọtụtụ ọkwa nke EGFRm NSCLC.
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-03-2025