Ulawulo lweMveliso yezonyango yeSizwe yaseTshayina (i-NMPA) luvumile i-PADCEVTM kunye ne-KEYTRUDA (pembrolizumab) yoNyango loMhlaza weSinyi oPhambili

Ngomhla wesi-8 kweyoMqungu, ngowama-2025, i-National Medical Products Administration (NMPA) yaseTshayina ivumile i-PADCEVTM (enfortumab vedotin) kunye ne-KEYTRUDA (pembrolizumab) kwizigulane zabantu abadala abanomhlaza we-urothelial oqhubele phambili okanye osasazekayo (la/mUC).

Ukuvunywa kwe-NMPA kwe-enfortumab vedotin kunye ne-pembrolizumab kuxhaswa ziziphumo ezivela kuvavanyo lweklinikhi lweSigaba sesi-3 se-EV-302 (ekwaziwa ngokuba yi-KEYNOTE-A39). Olu vavanyo lubonise ukuba indibaniselwano yonyango iphucule ukusinda okuqhelekileyo (OS) kunye nokusinda okungapheliyo (PFS) kunye neziphumo ezibalulekileyo ngokwezibalo kunye neziphumo ezibalulekileyo kwizigulane ezine-la/mUC enganyangwanga ngaphambili xa kuthelekiswa ne-chemotherapy equlethe i-platinum. I-OS ephakathi yeenyanga ezingama-31.5 (95% CI: 25.4-NR) ifezekisiwe ngokudibanisa unyango xa kuthelekiswa neenyanga ezili-16.1 (95% CI: 13.9-18.3) kunye ne-chemotherapy equlethe i-platinum, emele ukwehla kwama-53% kumngcipheko wokufa (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.38-0.58; P<0.00001). I-PFS ephakathi yeenyanga ezili-12.5 (95% CI: 10.4-16.6) ibikwe ngokudibanisa unyango xa kuthelekiswa neenyanga eziyi-6.3 (95% CI: 6.2-6.5) nge-chemotherapy equlethe iplatinum, nto leyo emele ukuncipha kwama-55% komngcipheko wokuqhubela phambili komhlaza okanye ukufa (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). Iziphumo zokhuseleko bezihambelana nezo bezixelwe ngaphambili ngolu kudibanisa unyango, kwaye akukho micimbi mitsha yokhuseleko efunyenweyo.

Malunga nomhlaza wesinyi kunye nomhlaza we-Urothelial
Umhlaza we-Urothelial, okanye umhlaza wesinyi, uqala kwiiseli ze-urothelial, ezikwi-urethra, kwisinyi, kwi-ureters, kwi-renal pelvis, nakwezinye izitho zomzimba.4 Umhlaza we-Urothelial ubangela i-90% yazo zonke iintlobo zomhlaza wesinyi kwaye unokufumaneka nakwi-renal pelvis, kwi-ureter, nakwi-urethra. Ukuba umhlaza wesinyi usasazeke kwizitho okanye kwimisipha ejikelezileyo, ubizwa ngokuba sisifo esiqhubekileyo kwindawo ethile. Ukuba umhlaza usasazeke kwezinye iindawo zomzimba, ubizwa ngokuba sisifo se-metastatic.8 Malunga ne-12% yamatyala aqhubekile kwindawo ethile okanye aqhubekekayo xa kuchongwa.

E-China, izinga lokwanda komhlaza wesinyi ngo-2022 libekwe kwindawo ye-11 phakathi kwazo zonke iintlobo zomhlaza, kunye namatyala amatsha angaphezu kwama-92,000 afunyaniswe ngaloo nyaka. Ukuxhaphaka kweminyaka emihlanu komhlaza wesinyi e-China kuqikelelwa ukuba yi-2.5/100,000 yamatyala, okanye amatyala angama-276,102. Unyango oluqhubekayo kunye nokubekwa esweni kwenza umhlaza wesinyi ube lolona hlobo lomhlaza lubiza kakhulu ebomini bomguli, kwaye ube ngumhlaza obiza kakhulu xa uthelekiswa nezinye izifo ezibangela umhlaza.

Malunga PADCEVTM (enfortumab vedotin)
I-PADCEV (enfortumab vedotin) yi-conjugate ye-antibody-drug yokuqala kwiklasi (ADC) ejoliswe kwi-Nectin-4, iprotheni efumaneka kumphezulu weeseli kwaye ibonakaliswa kakhulu kumhlaza wesinyi. Idatha engekho yeklinikhi ibonisa ukuba umsebenzi we-enfortumab vedotin wokulwa nomhlaza ubangelwa kukubopha kwayo kwiiseli eziveza i-Nectin-4, kulandele ukwenziwa ngaphakathi kunye nokukhululwa kwe-anti-tumor agent monomethyl auristatin E (MMAE) kwiseli, nto leyo ebangela ukuba iseli ingazalisi (ukubanjwa komjikelo weseli) kunye nokufa kweseli okucwangcisiweyo (i-apoptosis).

I-PADCEV iboniswa eTshayina njengonyango olulodwa lokunyanga izigulane zabantu abadala abanomhlaza we-urothelial ophucukileyo okanye osasazekayo emva konyango lwangaphambili nge-chemotherapy equlethe i-platinum kunye ne-programmed death receptor-1 (PD-1) okanye i-programmed death-ligand 1 (PD-L1) inhibitors, kwaye idibene ne-KEYTRUDA (pembrolizumab) kwizigulane zabantu abadala abanomhlaza we-urothelial ophucukileyo okanye osasazekayo.

Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.

Inombolo yefowuni: 4008803716

Email：myimmnet@163.com

Iireferensi

1.国家药品监督管理局 (nmpa.gov.cn)

2.Astellas Iphepha lasekhaya | Inkampani Astellas Pharma Inc.

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