Sangano reNational Medical Products Administration (NMPA) reChina rakabvumidza PADCEVTM pamwe chete neKEYTRUDA (pembrolizumab) yekurapa Cancer yeDundira Rakakura

Musi wa8 Ndira, 2025, National Medical Products Administration (NMPA) yeChina yakabvumidza PADCEVTM (enfortumab vedotin) pamwe chete neKEYTRUDA (pembrolizumab) kuvarwere vakuru vane kenza yemudumbu yakakwira kana kuti metastatic urothelial cancer (la/mUC).

Kubvumidzwa kweNMPA kwe enfortumab vedotin pamwe chete ne pembrolizumab kunotsigirwa nemigumisiro yePhase 3 EV-302 clinical trial (inozivikanwawo seKEYNOTE-A39). Kuedzwa kwakaratidza kuti musanganiswa wekurapa wakavandudza median overall survival (OS) uye median progression-free survival (PFS) nemigumisiro yakakosha uye ine revo mukurapa muvarwere vane la/mUC vasati vamborapwa zvichienzaniswa ne platinum-containing chemotherapy. Median OS yemwedzi 31.5 (95% CI: 25.4-NR) yakawanikwa ne musanganiswa wekurapa zvichienzaniswa nemwedzi 16.1 (95% CI: 13.9-18.3) ne platinum-containing chemotherapy, zvichireva kudzikira kwe53% munjodzi yekufa (Hazard Ratio [HR]=0.47; 95% Confidence Interval [CI]: 0.38-0.58; P<0.00001). Avhareji yePFS yemwedzi 12.5 (95% CI: 10.4-16.6) yakataurwa nekurapwa kwacho zvichienzaniswa nemwedzi 6.3 (95% CI: 6.2-6.5) ne platinum-containing chemotherapy, zvichireva kudzikira kwe55% munjodzi yekukura kwekenza kana kufa (HR=0.45; 95% CI: (0.38-0.54); P<0.00001). Mhedzisiro yekuchengetedzeka yaienderana neyakambotaurwa nekurapwa uku, uye hapana matambudziko matsva ekuchengetedza akaonekwa.

Nezve Dundira neGomarara reUrothelial
Kenza yemudumbu, kana kuti kenza yedundira, inotanga mumasero emudumbu, ayo ari muurethra, dundira, ureters, pelvis yetsvo, nedzimwe nhengo dzemuviri.4 Kenza yemudumbu inoumba 90% yekenza dzese dzedundira uye inogona kuwanikwawo mudundira retsvo, ureter, uye urethra. Kana kenza yedundira yapararira kune nhengo kana tsandanyama dzakapoteredza, inonzi chirwere chakakwira munharaunda. Kana kenza yapararira kune dzimwe nhengo dzemuviri, inonzi chirwere chemetastatic.8 Inenge 12% yezviitiko ikenza yemetastatic kana metastatic urothelial panguva yekuongororwa.

MuChina, huwandu hwevanhu vane kenza yedundira muna 2022 hwakanga huri panhamba 11 pakati pemagomarara ese, nevanhu vatsva vanodarika 92,000 vakaonekwa gore iroro. Kuwanda kwegomarara redundira kwemakore mashanu muChina kunofungidzirwa kuva 2.5/100,000, kana kuti 276,102. Kurapwa nguva dzose uye kutariswa kunoita kuti gomarara redundira rive rimwe remhando dzegomarara dzinodhura zvikuru muhupenyu hwemurwere, uye kenza inodhura zvakanyanya kana ichienzaniswa nedzimwe gomarara.

Pamusoro pePADCEVTM (enfortumab vedotin)
PADCEV (enfortumab vedotin) imushonga wekutanga mukirasi yeantibody-drug conjugate (ADC) unorwisa Nectin-4, puroteni iri pamusoro pemasero uye unoratidzwa zvakanyanya mukenza yedundira. Ruzivo rusiri rwekiriniki runoratidza kuti basa rekurwisa kenza re enfortumab vedotin rinokonzerwa nekusunga kwayo kumasero anotsanangura Nectin-4, zvichiteverwa nekuisa mukati nekuburitsa mushonga unodzivirira tumor monomethyl auristatin E (MMAE) mumasero, izvo zvinoita kuti sero risabereke (kumira kwemasero) uye kufa kwemasero kwakarongwa (apoptosis).

PADCEV inoratidzwa muChina semushonga wekurapa varwere vakuru vane kenza yemudumbu yakapararira kana kuti yakapararira mushure mekurapwa kare ne platinum-containing chemotherapy uye programmed death receptor-1 (PD-1) kana programmed death-ligand 1 (PD-L1) inhibitors, uye pamwe chete neKEYTRUDA (pembrolizumab) kune varwere vakuru vane kenza yemudumbu yakapararira kana yakapararira munharaunda.

Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.

Nhamba yefoni: 4008803716

Email：myimmnet@163.com

Mareferensi

1.国家药品监督管理局 (nmpa.gov.cn)

2.Astellas Home page | Nhoroondo ye Astellas Pharma Inc.

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