Ivunyiwe yi-NMPA yi-Senaparib yoNyango loLondolozo lwe-1L kuMhlaza we-Ovarian

Ngomhla we-16 kweyoMqungu, ngo-2025, i-IMPACT yabhengeza ukuba iiCapsules zeSenaparib (派舒宁®）zifumene imvume yokuthengisa eTshayina kwiNational Medical Products Administration (NMPA) njenge-monotherapy yonyango lokugcina izigulane zabantu abadala abane-epithelial advanced (FIGO Stages III and IV) high-grade ovarian, fallopian tube okanye primary peritoneal cancer abasabela (ngokupheleleyo okanye ngokungaphelelanga) emva kokugqitywa kwe-chemotherapy yokuqala esekelwe kwiplatinum.

ISenaparib, efunyenwe kwaye yaphuhliswa yi-IMPACT, sisithinteli sePARP 1/2 esinamandla nesintsha. Ulwakhiwo lwayo oluhlukileyo lwemolekyuli luyinika umsebenzi ophezulu we-in vitro kunye ne-in vivo, ukukhetha okujolise kuko okugqwesileyo kunye nefestile yokhuseleko olubanzi. Imvume isekelwe kwiFLAMES Study. Olu phononongo luphononongo lweklinikhi olucwangcisiweyo, olungaboni kabini, olulawulwa yi-placebo, oluneziko elininzi, lwesigaba sesithathu sokuvavanya ukusebenza kakuhle kunye nokhuseleko lweSenaparib njengonyango olulodwa lonyango lokugcina izigulane ezinomhlaza we-ovarian oqhubekileyo kwaye zigqibile i-chemotherapy yomgca wokuqala kwaye zifumene impendulo epheleleyo (CR) okanye impendulo engaphelelanga (PR). Iziphumo zeFLAMES Study zibonise ukuba iSenaparib ibonakalise ukuphucuka okukhulu kwi-PFS ephakathi xa kuthelekiswa ne-placebo (i-PFS ayifikelelwanga ngokuchasene neenyanga ezili-13.6, i-HR 0.43, P < 0.0001), nokuba imeko ye-BRCA injani. ISenaparib ibonakalise iprofayili yokhuseleko enokunyamezeleka, ngaphandle kweengxaki zokhuseleko ezibonakalayo. [1] Iziphumo zikwabonise ukuba zombini ii-HRD ezilungileyo kunye ne-HRD ezimbi zifumene inzuzo kunyango lokugcinwa kweSenaparib, zigxininisa amandla eSenaparib kwisicelo seklinikhi esibanzi. Iziphumo zolu phononongo ziya kuyixhasa kakhulu iSenaparib njengoMgangatho woNyango lonyango lolondolozo lokuqala kwizigulane ezisandula ukuxilongwa njengomhlaza wesibeleko.

Iziphumo eziphambili zolu phononongo zaqala zaboniswa njengomboniso womlomo ophumileyo emva kwexesha kwi-ESMO ngo-2023 zaza zaboniswa kwi-CSCO 2024. Ngomhla we-15 kuMeyi, ngo-2024, ijenali yezonyango edumileyo kwihlabathi liphela i-Nature Medicine nayo yapapasha iziphumo ezinesihloko esithi “iSenaparib njengonyango lolondolozo lomgca wokuqala kumhlaza we-ovarian oqhubekileyo: uvavanyo lwesigaba sesi-3 olucwangcisiweyo.”

Umhlaza wesibeleko sesinye sezona zifo zibulalayo zokuzala kwabasetyhini. Ngokwedatha ye-GLOBOCAN 2020, ukwanda komhlaza wesibeleko kwihlabathi liphela kufikelele kwi-310,000 yamatyala kwaye ukufa kufikelele kwi-210,000. Ngokwezibalo zomhlaza zesizwe zamva nje ezikhutshwe yiNational Cancer Center ngo-2024, bekukho amatyala amatsha angama-61,100 omhlaza wesibeleko kunye nokufa okungama-32,600 eTshayina ngo-2022, nto leyo eyenza ukuba ibe lelona thumba libulalayo kakhulu lesibeleko. Ngenxa yeempawu zokuqala zomhlaza wesibeleko ezingabonakaliyo nezingabonakaliyo, malunga nama-80% ezigulana sele zikwinqanaba eliphezulu xa zifunyaniswa, kwaye izinga lokusinda kweminyaka emi-5 liyi-41.8% kuphela. Nangona umhlaza wesibeleko unokulungiswa emva kwe-chemotherapy yokuqala equlethe iplatinum, uninzi lwezigulane ngokungenakuphepheka lujongana nokubuyela umva, kwaye kusekho isidingo esikhulu seklinikhi esingafezekiswanga sonyango kubantu abanesifo somhlaza wesibeleko.

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.https://www.prnewswire.com/news-releases/senaparib-approved-by-nmpa-for-1l-maintenance-therapy-in-ovarian-cancer-302353885.html