A kwadoro Finotonlimab maka iji ya agwọ ọrịa kansa squamous cell nke isi na olu

Na Febụwarị 8, 2025, National Medical Products Administration (NMPA) nke China akwadola finotonlimab nke Sinocelltech Group Ltd, nke bụ usoro ọgwụgwọ monoclonal antibody (mAb) nke a na-akpọ "programmed-death 1 (PD-1), maka iji ya na ọgwụ chemotherapy nke dabeere na platinum dị ka ọgwụgwọ mbụ maka ọrịa kansa squamous cell na-emegharị ugboro ugboro na/ma ọ bụ metastatic metastatic nke isi na olu.

Finotonlimab bụ ọgwụ mgbochi PD-1 monoclonal nke a na-akpọ IgG4 nke nwere ụdị ihe mgbochi PD-1 nke nwere ikike ọgụgụ isi zuru oke. Dịka ọgwụ ọhụrụ a na-enweta ikike, nhazi molekul ya pụrụ iche ma nwee uru usoro. Finotonlimab na-ejikọ na PD-1 nke ọma, na-egbochi ụzọ PD-1/PD-L1 nke ọma, na-eweghachi ma na-eme ka ọrụ igbu mkpụrụ ndụ T dịkwuo mma, ma si otú a na-egbochi uto nke etuto ahụ.

ANnwale nke usoro nke atọ nke a na-eme n'enweghị usoro, nke a na-ahụ anya ugboro abụọ, nyochachara irè na nchekwa nke finotonlimab (SCT-I10A), ọgwụ mgbochi monoclonal nke mkpụrụ ndụ 1 (PD-1), nke a na-akpọ "programmed cell death 1" (PD-1), jikọtara ya na cisplatin gbakwunyere 5-fluorouracil (C5F) maka ọgwụgwọ mbụ nke R/M HNSCC. E kenyere ndị ọrịa ruru eru (n = 370) 2:1 na usoro 2:1 iji nata finotonlimab gbakwunyere C5F (n = 247) ma ọ bụ placebo gbakwunyere C5F (n = 123). Isi ihe dị mkpa bụ ndụ zuru oke (OS). Na otu finotonlimab gbakwunyere C5F, OS bụ ọnwa 14.1 (95% confidence interval (CI) 11.1–16.4), ma e jiri ya tụnyere ọnwa 10.5 (95% CI 8.1–11.8) na placebo gbakwunyere otu C5F. Oke ihe egwu ahụ bụ 0.73 (95% CI 0.57–0.95, P = 0.0165), na-emezu ihe achọrọ maka njedebe mbụ. Finotonlimab gbakwunyere C5F gosipụtara oke OS dị elu ma e jiri ya tụnyere naanị C5F na profaịlụ nchekwa a na-anabata na R/M HNSCC, na-akwado ojiji ya dị ka nhọrọ ọgwụgwọ mbụ maka R/M HNSCC. Nsonaazụ ndị a na-egosi irè na nchekwa nke njikọta finotonlimab na C5F na ndị ọrịa Eshia nwere R/M HNSCC.

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.国家药品监督管理局 (nmpa.gov.cn)

2.Finotonlimab nwere chemotherapy na kansa isi na olu ugboro ugboro ma ọ bụ nke gbawara agbawa: nnwale nke usoro nke atọ | Ọgwụ Okike