Janaayo 8, 2025, Maamulka Badeecadaha Caafimaadka Qaranka ee Shiinaha (NMPA) ayaa ansixiyay PADCEVTM (enfortumab vedotin) oo ay weheliso KEYTRUDA (pembrolizumab) bukaanada qaangaarka ah ee qaba kansarka kaadi-mareenka ee maxalliga ah ama kansarka kaadi-mareenka ee faafa (la/mUC).
Ansixinta NMPA ee enfortumab vedotin oo lagu daray pembrolizumab waxaa taageeraya natiijooyinka ka soo baxay tijaabada kiliinikada ee Wajiga 3aad ee EV-302 (sidoo kale loo yaqaan KEYNOTE-A39). Tijaabadu waxay muujisay in isku-darka daaweyntu uu wanaajiyay badbaadada guud ee dhexdhexaadka ah (OS) iyo badbaadada aan horumarka lahayn ee dhexdhexaadka ah (PFS) iyadoo natiijooyin tirakoob ahaan muhiim ah oo macno caafimaad leh ay ka heleen bukaanada qaba la/mUC aan hore loo daaweyn marka la barbar dhigo kiimoterabiga ku jira platinum. OS dhexdhexaad ah oo ah 31.5 bilood (95% CI: 25.4-NR) ayaa lagu gaaray isku-darka daaweynta marka la barbar dhigo 16.1 bilood (95% CI: 13.9-18.3) oo leh kiimoterabiga ku jira platinum, taasoo ka dhigan hoos u dhac 53% ah oo ku yimid khatarta dhimashada (Saamaynta Khatarta [HR]=0.47; 95% Kala-fogeynta Kalsoonida [CI]: 0.38-0.58; P<0.00001). Celceliska PFS ee 12.5 bilood (95% CI: 10.4-16.6) ayaa lagu soo warramey isku darka daaweynta marka la barbar dhigo 6.3 bilood (95% CI: 6.2-6.5) oo leh kiimoterabiga platinum-ka ku jira, taasoo ka dhigan hoos u dhac 55% ah oo ku yimid khatarta kansarka ama dhimashada (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). Natiijooyinka badbaadadu waxay la mid ahaayeen kuwii hore loogu soo sheegay isku darka daaweyntan, mana jirin wax arrimo badbaado oo cusub ah oo la aqoonsaday.
Ku saabsan Kansarka Kaadiheysta iyo Kansarka Urothelial
Kansarka kaadi-mareenka, ama kansarka kaadiheysta, wuxuu ka bilaabmaa unugyada kaadi-mareenka, kuwaas oo ku yaal kaadi mareenka, kaadi haysta, kaadi haysta, miskaha kelyaha, iyo xubno kale.4 Kansarka kaadi-mareenka wuxuu ka tirsan yahay 90% dhammaan kansarka kaadiheysta waxaana sidoo kale laga heli karaa miskaha kelyaha, kaadi haysta, iyo kaadi mareenka. Haddii kansarka kaadi haysta uu ku faafo xubnaha ama muruqyada ku xeeran, waxaa loo yaqaan cudur maxalli ah oo horumarsan. Haddii kansarku ku faafo qaybaha kale ee jirka, waxaa loo yaqaan cudur faafa.8 Qiyaastii 12% kiisaska waa kansarka kaadi haysta ee maxalliga ah oo horumarsan ama metastatic ah marka la ogaado.
Dalka Shiinaha, heerka dhacdooyinka kansarka kaadiheysta sanadka 2022 wuxuu galay kaalinta 11aad ee dhammaan kansarrada, iyadoo in ka badan 92,000 oo kiis oo cusub la ogaaday sanadkaas. Shanta sano ee cudurka kansarka kaadiheysta ee Shiinaha waxaa lagu qiyaasay inuu yahay 2.5/100,000 oo kiis, ama 276,102 kiis. Daaweynta iyo la socodka joogtada ah waxay ka dhigaysaa kansarka kaadiheysta mid ka mid ah noocyada kansarka ugu qaalisan inta uu bukaanku nool yahay, iyo kansarka ugu qaalisan marka la barbar dhigo kansarrada kale ee kansarka.
Ku saabsan PADCEVTM (enfortumab vedotin)
PADCEV (enfortumab vedotin) waa isku-darka daawada antibody-ga ee heerka koowaad (ADC) kaas oo ka dhan ah Nectin-4, oo ah borotiin ku yaal dusha sare ee unugyada oo si weyn loogu muujiyo kansarka kaadiheysta. Xogta aan kiliinikada ahayn waxay soo jeedinaysaa in dhaqdhaqaaqa ka hortagga kansarka ee enfortumab vedotin ay sabab u tahay ku xidhnaantiisa unugyada muujinaya Nectin-4, oo ay ku xigto gudaha iyo sii deynta wakiilka ka hortagga burooyinka monomethyl auristatin E (MMAE) ee unugga, taasoo keenta in unuggu uusan tarmin (xidhitaanka wareegga unugyada) iyo dhimashada unugyada ee la qorsheeyay (apoptosis).
PADCEV waxaa loogu talagalay Shiinaha sidii daaweyn hal-hal ah oo loogu talagalay bukaanada qaangaarka ah ee qaba kansarka kaadi-mareenka ee maxalliga ah ama kansarka kaadi-mareenka ee maxalliga ah ka dib markii hore loo daaweeyay kiimoterabiga platinum-ka ku jira iyo receptor-ka dhimashada ee barnaamijka lagu sameeyay-1 (PD-1) ama hakiyeyaasha dhimashada-ligand 1 (PD-L1) ee barnaamijka lagu sameeyay, iyo iyadoo lagu darayo KEYTRUDA (pembrolizumab) bukaanada qaangaarka ah ee qaba kansarka kaadi-mareenka ee maxalliga ah ee horumarsan ama metastatic.
Waqtigan xaadirka ah, waxaa weli jira tijaabooyin caafimaad oo badan oo ku saabsan teknoolojiyada cusub ee ka hortagga kansarka ee Shiinaha oo raadinaya bukaanno. La-tashi ku saabsan daawooyinka cusub iyo teknoolojiyada, waxaad la xiriiri kartaa Waaxda Caalamiga ah ee Isbitaalka Oncology ee Gobolka Koonfureed ee Beijing.
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Tixraacyada
2.Astellas Home page | Hal qayb oo ka mid ah Astellas Pharma Inc.
3.https://www.nejm.org/doi/full/10.1056/NEJMoa2035807
Waqtiga boostada: Febraayo-21-2025