Na Disemba 04, 2024, enyerela ikike maka ojiji ọgwụ ọhụrụ (NDA) maka njikọta nke TYVYT® (ọgwụ sintilimab) na ELUNATE® (fruquintinib) na China maka ọgwụgwọ ndị ọrịa nwere kansa endometrial dị elu nwere etuto Mismatch Repair proficient (pMMR) ndị dara ọgwụgwọ sistemu gara aga ma bụrụ ndị a na-agaghị anabata ịwa ahụ ma ọ bụ radieshon. Nkwado a na-esochi ọnọdụ nyocha mbụ na aha ọgwụgwọ nke National Medical Products Administration (NMPA) nke China ma na-egosi ihe ngosi nke asatọ akwadoro maka TYVYT® (ọgwụ sintilimab).
Nkwado nke NMPA kwadoro site na data ọkwa ndebanye aha sitere na FRUSICA-1, otu ndị na-edebanye aha kansa endometrial nke ọmụmụ ihe Phase 2 nke ọtụtụ etiti, nke mepere emepe nke na-enyocha sintilimab yana fruquintinib na ndị ọrịa kansa endometrial bụ ndị nwere ọrịa nlọghachi, ọganihu ọrịa ma ọ bụ nsí a na-apụghị ịnagide site na ọgwụgwọ na ọgwụ chemotherapy nke dabeere na platinum. E gosipụtara nsonaazụ sitere na FRUSICA-1 na nzukọ kwa afọ nke American Society of Clinical Oncology na June 2024.
AE debara aha mmadụ 98 nwere ọnọdụ pMMR ma nata ọgwụgwọ njikọta ahụ. Ndị niile natara ọgwụgwọ sistemu platinum nke nwere usoro mbụ, pasentị 22.4 enwetala ọgwụgwọ bevacizumab. A chịkọtara akụkọ ọrịa zuru ezu na tebụl. Site na oge nleba anya etiti (95% CI) nke 15.7m (14.6, 17.7), pasentị 87/98 nwere opekata mpe otu nsonaazụ nyocha etuto ahụ mgbe mmalite (nleba anya arụmọrụ), n'ime ha, ORR na DCR nke IRC tụlere bụ 35.6% (CR: 2/87 na PR: 29/87) na 88.5% n'otu n'otu; eruteghị DoR na ọnụego 9m-DoR bụ 80.7%. N'ime pasent 98, ọnụọgụgụ PFS na OS nke etiti (95% CI) bụ 9.5m (5.6, -) na 21.3m (17.3, -) n'otu n'otu. Dabere na ọgwụgwọ bevacizumab gara aga, ORR bụ 40.9% megide 30.3%, ebe ọnụọgụgụ PFS nke etiti (95% CI) bụ 13.8m (4.1, -) megide 9.5m (5.5, -).
Ihe ọjọọ ndị a na-eme kwekọrọ na nke a kọrọ maka ọgwụgwọ immunotherapy na antiangiogenic yiri ya.
Banyere Sintilimab
Sintilimab, nke a na-ere dị ka TYVYT (ọgwụ injection sintilimab) na China, bụ ọgwụ mgbochi monoclonal PD-1 immunoglobulin G4 nke Innovent na Eli Lilly and Company mepụtara. Sintilimab bụ ụdị ọgwụ mgbochi monoclonal immunoglobulin G4, nke na-ejikọ na molekul PD-1 n'elu mkpụrụ ndụ T, na-egbochi ụzọ PD-1 / PD-Ligand 1 (PD-L1), ma na-emegharị mkpụrụ ndụ T iji gbuo mkpụrụ ndụ kansa. Na China, akwadoro sintilimab ma tinye ya na NRDL emelitere maka ihe ngosi asaa. Oke nkwụghachi ụgwọ NRDL emelitere maka ọgwụ TYVYT (ọgwụ injection sintilimab) gụnyere:
Maka ọgwụgwọ nke ọrịa Hodgkin's lymphoma nke na-alọghachi azụ ma ọ bụ nke na-adịghị mma mgbe ejiri usoro ọgwụgwọ chemotherapy ugboro abụọ ma ọ bụ karịa;
Maka ọgwụgwọ mbụ nke ọrịa kansa akpa ume nke na-adịghị ewepụ ihe ndị dị n'ime obodo ma ọ bụ nke na-abụghị nke a na-akpọ squamous nke na-abụghị obere mkpụrụ ndụ na-enweghị mgbanwe mkpụrụ ndụ ihe nketa EGFR ma ọ bụ ALK;
Maka ọgwụgwọ nke ndị ọrịa nwere ọrịa kansa akpa ume nke EGFR gbanwere n'ógbè ma ọ bụ nke na-abụghị obere mkpụrụ ndụ nke na-abụghị nke squamous nke na-abụghị obere mkpụrụ ndụ ndị gara n'ihu mgbe ọgwụgwọ EGFR-TKI gasịrị;
Maka ọgwụgwọ mbụ nke ọrịa kansa akpa ume nke na-adịghị ewepụ nke ọma n'ógbè ma ọ bụ nke na-abụghị obere mkpụrụ ndụ kansa akpa ume nke a na-apụghị iwepụ;
Maka ọgwụgwọ mbụ nke kansa hepatocellular carcinoma nke a na-apụghị iwepụ ma ọ bụ nke metastatic na-enweghị ọgwụgwọ usoro mbụ;
Maka ọgwụgwọ mbụ nke kansa squamous cell esophageal nke a na-apụghị iwepụ n'ógbè, nke na-emegharị ugboro ugboro ma ọ bụ nke na-akpata ọrịa kansa;
Maka ọgwụgwọ mbụ nke ọrịa kansa afọ nke na-adịghị ewepụ ihe ndị dị n'ime ahụ, nke na-emeghachi omume ma ọ bụ nke na-eme ka afọ gbapụ ma ọ bụ nke na-adịghị emegharị ahụ.
Ọzọkwa, NMPA kwadoro ihe ngosi nke asatọ nke sintilimab, yana fruquintinib maka ọgwụgwọ ndị ọrịa nwere kansa endometrial dị elu nwere etuto pMMR nke dara ọgwụgwọ sistemu mbụ ma na-abụghị ndị a ga-anwale maka ịwa ahụ ma ọ bụ radieshon, na Disemba 2024.
Na mgbakwunye, ọmụmụ ihe abụọ gbasara ọgwụgwọ nke sintilimab emezuola isi ihe ndị bụ isi ha:
Ọmụmụ nke usoro nke abụọ nke sintilimab monotherapy dị ka ọgwụgwọ nke abụọ nke kansa mkpụrụ ndụ esophageal squamous;
Ọmụmụ nke usoro nke atọ nke sintilimab monotherapy dị ka ọgwụgwọ nke abụọ maka kansa akpa ume nke na-abụghị obere mkpụrụ ndụ squamous nke nwere ọganihu ọrịa mgbe ọgwụgwọ chemotherapy dabere na platinum gasịrị.
Banyere Fruquintinib
Fruquintinib bụ ọgwụ na-egbochi ihe atọ niile na-anabata ihe na-eme ka endothelial growth factor (“VEGF”) (VEGFR-1, -2 na -3) n'ọnụ. Ndị na-egbochi VEGFR na-arụ ọrụ dị mkpa n'igbochi angiogenesis nke etuto ahụ. E mere Fruquintinib ka o nwee nhọrọ ka mma nke na-egbochi ọrụ kinase na-abụghị nke ebumnuche, na-enye ohere maka ikpughe ọgwụ nke na-enweta mgbochi ebumnuche na mgbanwe maka ojiji nwere ike ịbụ akụkụ nke ọgwụgwọ njikọta.
A kwadoro Fruquintinib maka ire ahịa maka ọgwụgwọ ndị ọrịa nwere kansa eriri afọ metastatic bụ ndị natarala fluoropyrimidine, oxaliplatin na irinotecan-based chemotherapy, yana ndị natara ma ọ bụ ndị na-adịghị mma maka ịnata ọgwụgwọ anti-VEGF ma ọ bụ ọgwụgwọ anti-epidemal growth factor receptor ("EGFR") (RAS wild-type) na China, ebe HUTCHMED na Eli Lilly and Company jikọrọ aka mepụta ma ree ya n'okpuru aha njirimara ELUNATE. E tinyere ya na ndepụta ọgwụ China National Reimbursement Drug List ("NRDL") na Jenụwarị 2020. Kemgbe mmalite ya na China, a gwọọla ihe karịrị ndị ọrịa 100,000 nwere kansa eriri afọ na fruquintinib.
Na Disemba 2024, NMPA kwadoro fruquintinib yana sintilimab maka ọgwụgwọ ndị ọrịa nwere kansa endometrial dị elu nwere etuto pMMR ndị dara ọgwụgwọ sistemu mbụ ma bụrụ ndị a na-agaghị anabata ịwa ahụ ma ọ bụ radieshon.
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.
Nọmba ekwentị: 4008803716
Ozi ịntanetị:myimmnet@163.com
Ntụaka
1.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20241203153537120.html
2.https://cn.innoventbio.com/#/news/592
3.https://meetings.asco.org/abstracts-presentations/234546
4.https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5619
5.https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.5619
Oge ozi: Disemba-16-2024