Ụlọ Ọrụ Nlekọta Ngwaahịa Ọgwụ Mba nke China (NMPA) kwadoro PADCEVTM yana KEYTRUDA (pembrolizumab) maka ọgwụgwọ nke kansa afọ ọsịsa dị elu.

Na Jenụwarị 8, 2025, Ụlọ Ọrụ Nlekọta Ngwaahịa Ọgwụ nke Mba China (NMPA) akwadola PADCEVTM (enfortumab vedotin) yana KEYTRUDA (pembrolizumab) maka ndị okenye nwere ọrịa kansa urothelial nke dị n'ógbè ahụ ma ọ bụ nke gbasaara ya (la/mUC).

Nkwenye NMPA nke enfortumab vedotin yana pembrolizumab na-akwado site na nsonaazụ sitere na nnwale ahụike nke Phase 3 EV-302 (nke a makwaara dị ka KEYNOTE-A39). Nnwale ahụ gosiri na njikọta ọgwụgwọ ahụ mere ka ndụ zuru oke (OS) na ndụ na-enweghị ọganihu (PFS) dịkwuo mma, yana nsonaazụ dị mkpa na nke bara uru n'ụlọ ọgwụ na ndị ọrịa nwere la/mUC a na-agwọbeghị mbụ ma e jiri ya tụnyere chemotherapy nwere platinum. E nwetara usoro OS nke ọnwa 31.5 (95% CI: 25.4-NR) site na njikọta ọgwụgwọ ma e jiri ya tụnyere ọnwa 16.1 (95% CI: 13.9-18.3) yana chemotherapy nwere platinum, nke na-anọchite anya mbelata 53% n'ihe ize ndụ nke ọnwụ (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.38-0.58; P<0.00001). A kọrọ na ọnụọgụ PFS nke ọnwa 12.5 (95% CI: 10.4-16.6) na njikọta ọgwụgwọ ma e jiri ya tụnyere ọnwa 6.3 (95% CI: 6.2-6.5) na chemotherapy nwere platinum, nke na-anọchite anya mbelata 55% na ihe egwu nke mmụba ọrịa kansa ma ọ bụ ọnwụ (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). Nsonaazụ nchekwa ahụ kwekọrọ na nke akọpụtara na mbụ na njikọta ọgwụgwọ a, achọpụtaghịkwa nsogbu nchekwa ọhụrụ.

Banyere Ọrịa Afụ na Ọrịa Urothelial
Ọrịa kansa urothelial, ma ọ bụ kansa eriri afọ, na-amalite na mkpụrụ ndụ urothelial, nke dị n'ime urethra, eriri afọ, ureters, akụrụ pelvis, na ụfọdụ akụkụ ahụ ndị ọzọ.4 Ọrịa kansa urothelial bụ 90% nke ọrịa kansa eriri afọ niile, a pụkwara ịchọtakwa ya na akụrụ pelvis, ureter, na urethra. Ọ bụrụ na ọrịa kansa eriri afọ agbasaala na akụkụ ahụ ma ọ bụ akwara gbara ya gburugburu, a na-akpọ ya ọrịa dị elu n'ógbè ahụ. Ọ bụrụ na ọrịa kansa agbasaala n'akụkụ ahụ ndị ọzọ, a na-akpọ ya ọrịa metastatic.8 Ihe dị ka 12% nke ikpe bụ ọrịa kansa urothelial dị elu n'ógbè ma ọ bụ metastatic n'oge nchọpụta.

Na Chaịna, ọnụọgụ ọrịa kansa eriri afọ na 2022 nọ n'ọkwa nke iri na otu n'ime ọrịa kansa niile, ebe a chọpụtara ihe karịrị ọrịa ọhụrụ 92,000 n'afọ ahụ. A na-eme atụmatụ na ọnụọgụ ọrịa kansa eriri afọ afọ ise na Chaịna bụ 2.5/100,000 ikpe, ma ọ bụ ikpe 276,102. Ọgwụgwọ na nlekota na-aga n'ihu na-eme ka ọrịa kansa eriri afọ bụrụ otu n'ime ụdị ọrịa kansa kachasị ọnụ n'oge ndụ onye ọrịa, na ọrịa kansa kachasị ọnụ ma e jiri ya tụnyere ọrịa kansa ndị ọzọ.

Banyere PADCEVTM (enfortumab vedotin)
PADCEV (enfortumab vedotin) bụ ọgwụ mgbochi ọrịa nke mbụ (ADC) nke a na-eduzi megide Nectin-4, protein dị n'elu mkpụrụ ndụ ma gosipụta nke ọma na kansa eriri afọ. Data ndị na-abụghị nke ahụike na-egosi na ọrụ mgbochi ọrịa kansa nke enfortumab vedotin bụ n'ihi njikọ ya na mkpụrụ ndụ Nectin-4 na-egosipụta, nke na-esochi ime na ntọhapụ nke ihe na-egbochi ọrịa kansa monomethyl auristatin E (MMAE) n'ime mkpụrụ ndụ ahụ, nke na-eme ka mkpụrụ ndụ ahụ ghara ịmụpụta ọzọ (njide okirikiri mkpụrụ ndụ) na ọnwụ mkpụrụ ndụ emebere (apoptosis).

A na-egosi PADCEV na China dị ka ọgwụgwọ otu maka ọgwụgwọ ndị toro eto nwere kansa urothelial dị elu ma ọ bụ nke metastatic mgbe ejiri ọgwụ chemotherapy nke nwere platinum na programmed death receptor-1 (PD-1) ma ọ bụ programmed death-ligand 1 (PD-L1) inhibitors, yana yana KEYTRUDA (pembrolizumab) maka ndị toro eto nwere kansa urothelial dị elu ma ọ bụ nke metastatic.

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.Astellas Home ibe | Ụlọ ọrụ Astellas Pharma Inc.

3.https://www.nejm.org/doi/full/10.1056/NEJMoa2035807