Bungwe la National Medical Products Administration (NMPA) la ku China Lavomereza PADCEVTM pamodzi ndi KEYTRUDA (pembrolizumab) pochiza khansa ya chikhodzodzo yapamwamba

Pa Januwale 8, 2025, bungwe la National Medical Products Administration (NMPA) la ku China lavomereza PADCEVTM (enfortumab vedotin) pamodzi ndi KEYTRUDA (pembrolizumab) kwa odwala akuluakulu omwe ali ndi khansa ya urothelial yodziwika bwino m'deralo (la/mUC).

Kuvomerezedwa kwa NMPA kwa enfortumab vedotin pamodzi ndi pembrolizumab kumathandizidwa ndi zotsatira za mayeso azachipatala a Phase 3 EV-302 (omwe amadziwikanso kuti KEYNOTE-A39). Mayesowa adawonetsa kuti kuphatikiza kwa chithandizochi kunathandizira kupulumuka kwapakati (OS) ndi kupulumuka kwapakati popanda kupitirira (PFS) ndi zotsatira zofunikira komanso zofunikira pachipatala mwa odwala omwe anali ndi la/mUC yomwe sinachiritsidwepo kale poyerekeza ndi chemotherapy yokhala ndi platinum. Opaleshoni yapakati ya miyezi 31.5 (95% CI: 25.4-NR) idachitika ndi kuphatikiza kwa chithandizochi poyerekeza ndi miyezi 16.1 (95% CI: 13.9-18.3) yokhala ndi chemotherapy yokhala ndi platinum, zomwe zikutanthauza kuchepetsa chiopsezo cha imfa ndi 53% (Hazard Ratio [HR] = 0.47; 95% Confidence Interval [CI]: 0.38-0.58; P<0.00001). PFS yapakati ya miyezi 12.5 (95% CI: 10.4-16.6) inanenedwa ndi kuphatikiza kwa chithandizo poyerekeza ndi miyezi 6.3 (95% CI: 6.2-6.5) ndi chemotherapy yokhala ndi platinum, zomwe zikutanthauza kuchepetsa kwa 55% pachiwopsezo cha khansa kapena imfa (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). Zotsatira za chitetezo zinali zofanana ndi zomwe zidanenedwa kale ndi kuphatikiza kwa chithandizochi, ndipo palibe mavuto atsopano achitetezo omwe adapezeka.

Zokhudza Khansa ya Chikhodzodzo ndi Urothelial
Khansa ya m'mimba, kapena khansa ya chikhodzodzo, imayamba m'maselo a m'mimba, omwe ali m'mbali mwa mkodzo, chikhodzodzo, mkodzo, m'chiuno cha impso, ndi ziwalo zina.4 Khansa ya m'mimba imapanga 90% ya khansa zonse za m'chikhodzodzo ndipo imapezekanso m'chiuno cha impso, m'mimba, ndi mkodzo. Ngati khansa ya m'chikhodzodzo yafalikira ku ziwalo kapena minofu yozungulira, imatchedwa matenda opitilira m'deralo. Ngati khansa yafalikira ku ziwalo zina za thupi, imatchedwa matenda opitilira m'thupi.8 Pafupifupi 12% ya milandu ndi khansa yopitilira m'deralo kapena yopitilira m'malo omwe amapezeka.

Ku China, kuchuluka kwa khansa ya chikhodzodzo mu 2022 kunali pa nambala 11 pakati pa khansa zonse, ndipo milandu yatsopano yoposa 92,000 inapezeka chaka chimenecho. Kufalikira kwa khansa ya chikhodzodzo kwa zaka zisanu ku China kukuyerekezeredwa kuti ndi 2.5 pa milandu 100,000, kapena milandu 276,102. Kuchiza mosalekeza ndi kuyang'aniridwa kumapangitsa khansa ya chikhodzodzo kukhala imodzi mwa mitundu yokwera mtengo kwambiri ya khansa pa moyo wonse wa wodwala, komanso khansa yokwera mtengo kwambiri poyerekeza ndi khansa zina.

Za PADCEVTM (enfortumab vedotin)
PADCEV (enfortumab vedotin) ndi mankhwala oyamba oletsa khansa otchedwa conjugate (ADC) omwe amalimbana ndi Nectin-4, puloteni yomwe ili pamwamba pa maselo ndipo imaonekera kwambiri mu khansa ya chikhodzodzo. Deta yosakhala yachipatala imasonyeza kuti ntchito ya enfortumab vedotin yolimbana ndi khansa imachitika chifukwa chakuti imalumikizana ndi maselo omwe amawonetsa Nectin-4, kenako imalowa mkati ndikutulutsa mankhwala oletsa khansa otchedwa monomethyl auristatin E (MMAE) mu selo, zomwe zimapangitsa kuti selo lisaberekenso (kumangidwa kwa maselo) komanso kufa kwa maselo (apoptosis).

PADCEV ikuwonetsedwa ku China ngati njira imodzi yothandizira odwala akuluakulu omwe ali ndi khansa ya urothelial yomwe yakula kwambiri kapena yofalikira kwambiri pambuyo pa chithandizo choyambirira ndi chemotherapy yokhala ndi platinum ndi programmed death receptor-1 (PD-1) kapena programmed death-ligand 1 (PD-L1) inhibitors, komanso kuphatikiza ndi KEYTRUDA (pembrolizumab) kwa odwala akuluakulu omwe ali ndi khansa ya urothelial yomwe yakula kwambiri kapena yofalikira kwambiri.

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.Tsamba la Astellas | Malingaliro a kampani Astellas Pharma Inc.

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