Finotonlimab yavomerezedwa kuti igwiritsidwe ntchito pa khansa ya squamous cell ya mutu ndi khosi

Pa February 8, 2025, bungwe la National Medical Products Administration (NMPA) la ku China lavomereza finotonlimab ya Sinocelltech Group Ltd, yomwe ndi antibody ya programmed-death 1 (PD-1) monoclonal (mAb), kuti igwiritsidwe ntchito limodzi ndi chemotherapy yochokera ku platinum ngati chithandizo choyamba cha khansa ya squamous cell carcinoma ya mutu ndi khosi yomwe imabwereranso.

Finotonlimab ndi antibody ya IgG4 yopangidwanso kuti ikhale yaumunthu yokhala ndi ufulu wonse wa chidziwitso. Monga mankhwala atsopano opangidwa ndi patent, kapangidwe kake ka mamolekyu ndi kapadera ndipo kali ndi ubwino wa njira. Finotonlimab imalumikizana ndi PD-1 ndi mphamvu yayikulu, ndikutseka njira ya PD-1/PD-L1, kubwezeretsa ndikuwonjezera ntchito yopha chitetezo cha mthupi ya maselo a T, motero kuletsa kukula kwa chotupa.

AMayeso a gawo lachitatu losasinthika, losawoneka bwino la double-blind adayesa mphamvu ndi chitetezo cha finotonlimab (SCT-I10A), antibody ya monoclonal ya kufa kwa maselo 1 (PD-1), yophatikizidwa ndi cisplatin kuphatikiza 5-fluorouracil (C5F) pa chithandizo choyamba cha R/M HNSCC. Odwala oyenerera (n = 370) adapatsidwa mwachisawawa 2:1 kuti alandire finotonlimab kuphatikiza C5F (n = 247) kapena placebo kuphatikiza C5F (n = 123). Mapeto ake akuluakulu anali kupulumuka konse (OS). Mu gulu la finotonlimab kuphatikiza C5F, OS inali miyezi 14.1 (95% nthawi yodzidalira (CI) 11.1–16.4), poyerekeza ndi miyezi 10.5 (95% CI 8.1–11.8) mu gulu la placebo kuphatikiza C5F. Chiŵerengero cha zoopsa chinali 0.73 (95% CI 0.57–0.95, P = 0.0165), zomwe zinakwaniritsa zofunikira zomwe zidafotokozedwa kale za kupambana kwa endpoint yoyamba. Finotonlimab kuphatikiza C5F zidawonetsa kupambana kwakukulu kwa OS poyerekeza ndi C5F yokha komanso mbiri yotetezeka yovomerezeka ndi R/M HNSCC, zomwe zikuthandizira kugwiritsidwa ntchito kwake ngati njira yoyamba yothandizira R/M HNSCC. Zotsatirazi zimatsimikizira kugwira ntchito bwino komanso chitetezo cha kuphatikiza finotonlimab ndi C5F mwa odwala aku Asia omwe ali ndi R/M HNSCC.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

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Zolemba

1.国家药品监督管理局 (nmpa.gov.cn)

2.Finotonlimab yokhala ndi chemotherapy mu khansa ya mutu ndi khosi yobwerezabwereza kapena yofalikira: mayeso osankhidwa mwachisawawa a gawo lachitatu | Nature Medicine