Musi wa31 Zvita, National Medical Products Administration (NMPA) yeChina yakabvumidza VYLOYTM (zolbetuximab), pamwe chete ne fluoropyrimidine- ne platinum-containing chemotherapy, yekurapa varwere vane an advanced local unresectable kana metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma vane tumors dziri claudin (CLDN) 18.2 positive. Zolbetuximab ndiyo yekutanga NMPA-approved monoclonal antibody kunanga gastric tumors cells dzinoratidza biomarker CLDN18.2, ichipa nzira yakanyanya kunangwa yekurapa cancer.
Kubvumidzwa kweNMPA kwe zolbetuximab kunotsigirwa nedata kubva mumiedzo yekiriniki yepasi rose yePhase 3 GLOW ne SPOTLIGHT iyo yaisanganisira varwere 145 ne36 vanobva kuChina, zvichiteerana. Muedzo we GLOW wakaongorora zolbetuximab pamwe neCAPOX (mushonga wekemotherapy unosanganisira capecitabine ne oxaliplatin) zvichienzaniswa ne placebo pamwe ne CAPOX. Muedzo we SPOTLIGHT wakaongorora zolbetuximab pamwe ne mFOLFOX6 (mushonga wekemotherapy unosanganisira oxaliplatin, leucovorin uye fluorouracil) zvichienzaniswa ne placebo pamwe ne mFOLFOX6.
Kuedzwa kweSPOTLIGHT kwakaongorora zolbetuximab pamwe nemFOLFOX6 (musanganiswa wemishonga inosanganisira oxaliplatin, leucovorin uye fluorouracil) zvichienzaniswa ne placebo pamwe ne mFOLFOX6. Kurapwa ne zolbetuximab kwakaratidzwa kuti kunopa kuvandudzwa kwakakosha mu progression-free survival (PFS) uye overal survival (OS) zvichienzaniswa nedzimwe standard of care chemotherapies muvarwere vanokodzera vane gastric cancer ne GEJ. Mukuyedzwa kwe GLOW, avhareji yePFS yemwedzi 8.21 yakawanikwa ne zolbetuximab pamwe ne CAPOX sekurapa kwekutanga zvichienzaniswa nemwedzi 6.80 ne placebo pamwe ne CAPOX. Avhareji yeOS yaive mwedzi 14.39 zvichienzaniswa nemwedzi 12.16 mumapoka ekurapwa akasiyana. Mhedzisiro yakafanana yekushanda zvakanaka yakaonekwa muongororo yeSPOTLIGHT, uko PFS yepakati yaive mwedzi 10.61 zvichienzaniswa nemwedzi 8.67, uye OS yepakati yaive mwedzi 18.23 zvichienzaniswa nemwedzi 15.54, nezolbetuximab pamwe nemFOLFOX6, zvichienzaniswa neplacebo pamwe nemFOLFOX6. Mumiedzo yeGLOW neyeSPOTLIGHT, kuwanda kwezviitiko zvakashata zvekurapa zvakanyanya (TEAEs) kwakafanana mumapoka ekurapwa ezolbetuximab zvichienzaniswa nevanorapa. MaTEAE akajairika akataurwa mumapoka ekurapwa ezolbetuximab aive kuda kurutsa, kurutsa uye kudzikira kwechido chekudya.
Mukuongorora kwakabatanidzwa, avhareji yekurarama pasina kufambira mberi yaive mwedzi 9.2 muboka rezolbetuximab uye mwedzi 8.2 muboka replacebo (hazard ratio yekufambira mberi kana kufa, 0.71; 95% confidence interval [CI], 0.61 kusvika 0.83). Huwandu hwevarwere 377 pa537 (70.2%) muboka rezolbetuximab uye 424 pavarwere 535 (79.3%) muboka replacebo vakafa. Avhareji yekurarama kwese yaive mwedzi 16.4 muboka rezolbetuximab uye mwedzi 13.7 muboka replacebo (hazard ratio yerufu, 0.77; 95% CI, 0.67 kusvika 0.89). Mhando dzemishonga inotevera yekurwisa kenza dzakaenzaniswa pakati pemapoka ekurapa.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
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ZVINOTAURWA
1.国家药监局批准注射用佐妥昔单抗上市 (nmpa.gov.cn)
Nguva yekutumira: Ndira-09-2025