Pasi pezita rekutengesa Trodelvy®, iyo US FDA yakambopa mvumo yekukurumidzira kuSG muna Kubvumbi 2020 uye yakawedzera chiratidzo chayo nemvumo yakazara muna Kubvumbi 2021 kuvarwere vakura vasina kurongeka munharaunda kana mTNBC vakagamuchira maviri kana anopfuura ekutanga maitiro ekurapa, pa chimwe chazvo chechirwere che metastatic. Muna Chivabvu 2021, Everest yakazivisa kuti China National Medical Products Administration yakagamuchira Biologics License Chikumbiro chayo nekutanga kuongororwa kweSG kune varwere vakura vane TNBC isingatarisike munharaunda yepamusoro kana metastatic TNBC vakagamuchira maviri kana anopfuura ekutanga maitiro ekurapa, angangoita imwe chete yadzo yemetastatic. chirwere.
Muna Mbudzi 2021, Everest yakazivisa mibairo yepamusoro yeChikamu 2b EVER-132-001 kudzidza kweSG, iyo yakasangana neyayo yekutanga magumo ne38.8% yehuwandu hwekupindura mwero (ORR). Chidzidzo ichi chaisanganisira vanhu makumi masere muChina, uye mhedzisiro yacho yaienderana neiyo yepasi rose Phase 80 ASCENT kudzidza, zvichiratidza kushanda kwakafanana muhuwandu hweChinese.
TNBC ndiyo yakanyanya hutsinye mhando yegomarara rezamu uye inoverengera ingangoita 15% yemazamu ese. Makore epakati ekuongororwa kenza yemazamu anowanzo kuve mudiki muAsia kupfuura nyika dzekumadokero, uye chikamu cheTNBC molecular subtype chave kuwedzera mumakore gumi apfuura. Masero eTNBC haana estrogen uye progesterone receptors uye ane mashoma epidermal kukura factor receptor 10 (HER2). Nekuda kwehunhu hweTNBC, nzira dzekurapa dzinoshanda dzakashomeka zvakanyanya kana zvichienzaniswa nedzimwe mhando dzegomarara rezamu. TNBC ine mukana wepamusoro wekudzoka uye metastases pane dzimwe mhando dzegomarara rezamu. Avhareji yenguva yekudzokororwa kwemetastatic yeTNBC ingangoita makore 2 zvichienzaniswa nemakore mashanu kune mamwe magomarara emazamu, uye mwero wemakore mashanu wekupona wakadzikira zvakanyanya. Pakati pevakadzi vane metastatic TNBC, mwero wemakore mashanu ekupona i2.6%, zvichienzaniswa ne5% kune avo vane mamwe marudzi ekenza yemazamu.
ZVOKUBVA MUNYAYA INO:
- Muna Chivabvu 2021, Everest yakazivisa kuti China National Medical Products Administration yakagamuchira Biologics License Chikumbiro chayo nekutanga kuongororwa kweSG kune varwere vakura vane TNBC isingatarisike munharaunda kana metastatic TNBC vakagamuchira maviri kana anopfuura ekutanga maitiro ekurapa, angangoita imwe chete yadzo yemetastatic. chirwere.
- FDA yakambopa mvumo yekukurumidzira kuSG muna Kubvumbi 2020 uye ndokuwedzera chiratidzo nemvumo yakazara muna Kubvumbi 2021 kune varwere vakuru vasina kurongeka munharaunda yepamusoro kana mTNBC vakagamuchira maviri kana anopfuura ekutanga maitiro ekurapa, angangoita imwe chete yechirwere chemetastatic.
- Makore epakati ekuongororwa kenza yemazamu anowanzo kuve mudiki muAsia kupfuura nyika dzekumadokero, uye chikamu cheTNBC molecular subtype chave kuwedzera mumakore gumi apfuura.
