Ụlọ Ọrụ Nlekọta Ngwaahịa Ọgwụ Mba nke China (NMPA) kwadoro VYLOYTM (zolbetuximab) maka ọgwụgwọ mbụ nke Adenocarcinoma afọ dị elu ma ọ bụ nke eriri afọ.

Na Disemba 31, National Medical Products Administration (NMPA) nke China akwadola VYLOYTM (zolbetuximab), yana ọgwụ chemotherapy nke nwere fluoropyrimidine na platinum, maka ọgwụgwọ mbụ nke ndị ọrịa nwere adenocarcinoma nke na-adịghị ahụkebe ma ọ bụ nke na-adịghị mma nke mmadụ nwere mpaghara dị elu ma ọ bụ nke na-adịghị ahụkebe nke na-anabata ihe nnabata 2 (HER2) nke na-adịghị mma nke na-eme ka ọnya afọ ma ọ bụ nke na-adịghị mma nke na-egosipụta claudin (CLDN) 18.2. Zolbetuximab bụ ọgwụ mgbochi monoclonal mbụ nke NMPA kwadoro iji lekwasị anya na mkpụrụ ndụ kansa afọ nke na-egosipụta ihe ngosi CLDN18.2, na-enye ụzọ dị elu maka ọgwụgwọ kansa.

Nkwenye NMPA maka zolbetuximab sitere na data sitere na nnwale ahụike nke Phase 3 GLOW na SPOTLIGHT zuru ụwa ọnụ, nke gụnyere ndị ọrịa 145 na 36 si mba China, n'otu n'otu. Nnwale GLOW tụlere zolbetuximab tinyere CAPOX (usoro ọgwụgwọ chemotherapy jikọtara ọnụ nke gụnyere capecitabine na oxaliplatin) ma e jiri ya tụnyere placebo gbakwunyere CAPOX. Nnwale SPOTLIGHT tụlere zolbetuximab gbakwunyere mFOLFOX6 (usoro ọgwụgwọ njikọta nke gụnyere oxaliplatin, leucovorin na fluorouracil) ma e jiri ya tụnyere placebo gbakwunyere mFOLFOX6.

Nnwale SPOTLIGHT nyochachara zolbetuximab tinyere mFOLFOX6 (usoro njikọta nke gụnyere oxaliplatin, leucovorin na fluorouracil) ma e jiri ya tụnyere placebo gbakwunyere mFOLFOX6. E gosiri na ọgwụgwọ zolbetuximab na-enye mmụba dị ukwuu na nlanarị na-enweghị ọganihu (PFS) na nlanarị zuru oke (OS) ma e jiri ya tụnyere usoro ọgwụgwọ kemoterapi ndị ọzọ na ndị ọrịa ruru eru nwere kansa afọ na GEJ. Na nnwale GLOW, e nwetara PFS nke ọnwa 8.21 site na iji zolbetuximab gbakwunyere CAPOX dị ka ọgwụgwọ mbụ ma e jiri ya tụnyere ọnwa 6.80 site na placebo gbakwunyere CAPOX. OS nke etiti bụ ọnwa 14.39 ma e jiri ya tụnyere ọnwa 12.16 na otu ọgwụgwọ dị iche iche. A hụrụ nsonaazụ arụmọrụ yiri nke ahụ na nnwale SPOTLIGHT, ebe etiti PFS bụ ọnwa 10.61 ma e jiri ya tụnyere ọnwa 8.67, ebe etiti OS bụ ọnwa 18.23 ma e jiri ya tụnyere ọnwa 15.54, yana zolbetuximab gbakwunyere mFOLFOX6, ma e jiri ya tụnyere placebo gbakwunyere mFOLFOX6. Na nnwale GLOW na SPOTLIGHT, ihe omume nke ihe omume ọjọọ (TEAEs) ọgwụgwọ siri ike yiri nke ahụ na otu ọgwụgwọ zolbetuximab ma e jiri ya tụnyere njikwa. Ndị TEAE kachasị na-akọ akụkọ na otu ọgwụgwọ zolbetuximab bụ ọgbụgbọ, ọgbụgbọ na agụụ belatara.

N'ime nyocha ejikọtara ọnụ, ndụ etiti nke enweghị ọganihu bụ ọnwa 9.2 n'ime otu zolbetuximab na ọnwa 8.2 n'ime otu placebo (oke ihe egwu maka ọganihu ma ọ bụ ọnwụ, 0.71; oge ntụkwasị obi 95% [CI], 0.61 ruo 0.83). Ngụkọta nke ndị ọrịa 377 n'ime 537 (70.2%) na otu zolbetuximab na mmadụ 424 n'ime ndị ọrịa 535 (79.3%) na otu placebo nwụrụ. Ndụ etiti bụ ọnwa 16.4 na otu zolbetuximab na ọnwa 13.7 na otu placebo (oke ihe egwu maka ọnwụ, 0.77; 95% CI, 0.67 ruo 0.89). Ụdị ọgwụgwọ mgbochi kansa ndị sochirinụ dị n'etiti otu ọgwụgwọ ahụ.

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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Ntụaka

1.国家药监局批准注射用佐妥昔单抗上市 (nmpa.gov.cn)

2.Zolbetuximab tinyere CAPOX na CLDN18.2-positive gastric or gastroesophageal junction adenocarcinoma: nnwale nke usoro 3 GLOW | Ọgwụ Okike

3.Zolbetuximab na Njikọ Afọ ma ọ bụ Gastroesophageal Adenocarcinoma | New England Journal of Medicine (nejm.org)

4.Zolbetuximab gbakwunyere mFOLFOX6 n'ime ndị ọrịa nwere CLDN18.2-positive, HER2-negative, a naghị agwọ ya, nke a na-anaghị agwọ ya nke ọma ma ọ bụ nke a na-anaghị agwọ ya nke ọma ma ọ bụ nke a na-anaghị agwọ ya nke ukwuu n'ime afọ ma ọ bụ eriri afọ na-adịghị ala ala (SPOTLIGHT): nnwale nke usoro 3 nke ọtụtụ ebe, nke a na-eme na randomized, nke a na-ahụ maka ihu abụọ.