Senaparib Yakagamuchirwa neNMPA ye1L Kurapa Kuchengetedza Gomarara reOvarian

Musi wa16 Ndira, 2025, IMPACT yakazivisa kuti Senaparib Capsules (派舒宁®）yakagamuchira mvumo yekutengesa muChina kubva kuNational Medical Products Administration (NMPA) semushonga wekurapa varwere vakuru vane kenza yepamusoro ye ovarian, fallopian tube kana primary peritoneal cancer vari kupindura (zvakazara kana kuti zvishoma) mushure mekupedza chemotherapy ye platinum yekutanga.

Senaparib, yakawanikwa uye yakagadzirwa neIMPACT, mushonga une simba uye mutsva wePARP 1/2 inhibitor. Maumbirwo ayo akasiyana emamorekuru anoipa basa rakawanda mu vitro uye mu vivo, kusarudza kwakasarudzika uye mukana wakakura wekuchengetedza. Kubvumidzwa kwacho kwakavakirwa paFLAMES Study. Chidzidzo ichi chidzidzo chekiriniki chechikamu chechitatu chegamuchidzanwa, chakaongororwa kaviri, chinodzorwa neplacebo, chine nzvimbo dzakawanda, chekuongorora kushanda uye kuchengetedzeka kweSenaparib sekurapa kwekuchengetedza varwere vane kenza ye ovarian yepamusoro avo vakapedza chemotherapy yekutanga uye vakawana mhinduro yakakwana (CR) kana mhinduro yechikamu (PR). Mhedzisiro yeFLAMES Study yakaratidza kuti Senaparib yakaratidza kuvandudzika kukuru muPFS yepakati zvichienzaniswa neplacebo (PFS isina kusvika vs 13.6 months, HR 0.43, P < 0.0001), zvisinei nemamiriro eBRCA. Senaparib yakaratidza kuchengetedzeka kunobvumirwa, pasina matambudziko anooneka ekuchengetedza. [1] Mhedzisiro yacho yakaratidzawo kuti vanhu vese vane HRD positive neHRD negative vakawana kubatsirwa kubva kuSenaparib maintenance therapy, zvichiratidza kugona kweSenaparib kushandiswa mukiriniki yakakura. Zvakabuda muchidzidzo ichi zvichatsigira zvakasimba Senaparib seStandard of Care yekurapa kwekutanga kwekuchengetedza varwere vane kenza yechibereko ichangobva kubatwa.

Mhedzisiro yepamusoro yechidzidzo ichi yakatanga kuratidzwa sehurukuro yemuromo yakanonoka kuburitswa paESMO muna 2023 uye yakaburitswa paCSCO 2024. Musi wa15 Chivabvu, 2024, magazini yezvekurapa inozivikanwa pasi rose yeNature Medicine yakaburitsawo mhinduro ine musoro unoti "Senaparib senzira yekutanga yekuchengetedza kenza yegomarara remazamu: bvunzo yechikamu chechitatu isina kurongeka."

Gomarara remazamu ndeimwe yegomarara rinouraya rinoitika kuvakadzi. Sekureva kwedata reGLOBOCAN 2020, huwandu hwevanhu vanobatwa negomarara remazamu pasi rose hunosvika 310,000 uye huwandu hwevanhu vanofa hunosvika 210,000. Sekureva kwenhamba dzegomarara remazamu dzakaburitswa neNational Cancer Center muna 2024, kwaive nezviitiko zvitsva 61,100 zvegomarara remazamu uye 32,600 vakafa muChina muna 2022, zvichiita kuti rive gomarara rinouraya zvakanyanya remazamu. Nekuda kwezviratidzo zvegomarara remazamu risinganyatsoonekwi, vanenge 80% yevarwere vanenge vatove padanho repamusoro pavanoonekwa, uye huwandu hwevanhu vanorarama kwemakore mashanu i41.8% chete. Kunyangwe gomarara remazamu richigona kugadziriswa mushure mekutanga chemotherapy ine platinum, varwere vazhinji vanotarisana nekudzokazve, uye kuchine kudiwa kukuru kwekurapwa muvarwere vane gomarara remazamu kusati kwazadzikiswa.

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