I te 31 o Hakihea, kua whakaaetia e te Whakahaere Hua Hauora ā-Motu o Haina (NMPA) te VYLOYTM (zolbetuximab), me te rongoā chemotherapy kei roto ko te fluoropyrimidine me te platinum, hei rongoā tuatahi mō ngā tūroro e pangia ana e te adenocarcinoma gastric, gastroesophageal junction (GEJ) adenocarcinoma kāore e taea te tango, te horapa rānei, ā, ko ō rātou pukupuku he claudin (CLDN) 18.2 pai. Ko Zolbetuximab te paturopi monoclonal tuatahi kua whakaaetia e te NMPA ki te aro ki ngā pūtau pukupuku gastric e whakaatu ana i te biomarker CLDN18.2, e tuku ana i tētahi huarahi tino aro ki te rongoā mate pukupuku.
Ko te whakaae a te NMPA ki te zolbetuximab e tautokona ana e ngā raraunga mai i ngā whakamātautau haumanu Wāhanga 3 o te ao, GLOW me SPOTLIGHT, i uru atu ki te 145 me te 36 tūroro mai i Haina matua. I arotakehia e te whakamātautau GLOW te zolbetuximab me te CAPOX (he maimoatanga chemotherapy whakakotahi kei roto ko te capecitabine me te oxaliplatin) i whakaritea ki te placebo me te CAPOX. I arotakehia e te whakamātautau SPOTLIGHT te zolbetuximab me te mFOLFOX6 (he maimoatanga whakakotahi kei roto ko te oxaliplatin, leucovorin me te fluorouracil) i whakaritea ki te placebo me te mFOLFOX6.
I arotakehia e te whakamātautau SPOTLIGHT te zolbetuximab me te mFOLFOX6 (he tikanga whakakotahi kei roto ko te oxaliplatin, leucovorin me te fluorouracil) ki te whakataurite ki te placebo me te mFOLFOX6. I whakaatuhia ko te maimoatanga ki te zolbetuximab he whakapainga nui ki te oranga kore-whakamua (PFS) me te oranga whānui (OS) ki te whakataurite ki ētahi atu rongoā chemotherapy paerewa tiaki i roto i ngā tūroro whai mana me ngā mate pukupuku puku me te GEJ. I roto i te whakamātautau GLOW, i tutuki he PFS toharite o te 8.21 marama me te zolbetuximab me te CAPOX hei maimoatanga raina tuatahi, ki te whakataurite ki te 6.80 marama me te placebo me te CAPOX. Ko te OS toharite he 14.39 marama ki te whakataurite ki te 12.16 marama i roto i ngā rōpū maimoatanga. I kitea ngā hua whai huatanga ōrite i roto i te whakamātautau SPOTLIGHT, ko te PFS toharite he 10.61 marama ki te 8.67 marama, ā, ko te OS toharite he 18.23 marama ki te 15.54 marama, me te zolbetuximab me te mFOLFOX6, ki te whakaritea ki te placebo me te mFOLFOX6. I roto i ngā whakamātautau GLOW me te SPOTLIGHT, he ōrite te auau o ngā pānga kino ohorere o te maimoatanga (TEAE) i roto i ngā rōpū maimoatanga zolbetuximab ki te whakaritea ki ngā mana whakahaere. Ko ngā TEAE katoa-taumata tino kitea i roto i ngā rōpū maimoatanga zolbetuximab ko te whakapairuaki, te ruaki me te heke o te hiahia kai.
I roto i te tātaritanga whakakotahi, ko te roanga oranga kore-whakahaerenga toharite he 9.2 marama i roto i te rōpū zolbetuximab me te 8.2 marama i roto i te rōpū placebo (ōwehenga mōrearea mō te whanaketanga, te mate rānei, 0.71; 95% wā whakawhirinaki [CI], 0.61 ki te 0.83). I mate te katoa o te 377 o te 537 tūroro (70.2%) i roto i te rōpū zolbetuximab me te 424 o te 535 tūroro (79.3%) i roto i te rōpū placebo. Ko te roanga oranga toharite whānui he 16.4 marama i roto i te rōpū zolbetuximab me te 13.7 marama i roto i te rōpū placebo (ōwehenga mōrearea mō te mate, 0.77; 95% CI, 0.67 ki te 0.89). I tauritehia ngā momo maimoatanga ārai matepukupuku i muri mai i waenga i ngā rōpū maimoatanga.
I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.
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NGĀ TOHUTORO
1.国家药监局批准注射用佐妥昔单抗上市 (nmpa.gov.cn)
Wā tuku: Hanuere-09-2025