Senaparib Yavomerezedwa ndi NMPA pa Chithandizo cha Kusamalira cha 1L mu Khansa ya M'chiberekero

Pa Januwale 16, 2025, IMPACT yalengeza kuti Senaparib Capsules (派舒宁®）yalandira chilolezo chotsatsa ku China kuchokera ku National Medical Products Administration (NMPA) ngati chithandizo chokhacho chochiritsira odwala akuluakulu omwe ali ndi khansa yapamwamba ya ovarian, fallopian tube kapena primary peritoneal cancer omwe ali ndi vuto (lonse kapena pang'ono) atamaliza kulandira chemotherapy yoyamba ya platinum.

Senaparib, yomwe idapezeka ndi kupangidwa ndi IMPACT, ndi mankhwala amphamvu komanso atsopano a PARP 1/2. Kapangidwe kake ka mamolekyulu kamapatsa mphamvu zambiri mu vitro ndi mu vivo, kusankha bwino kwambiri komanso chitetezo chokwanira. Kuvomerezedwa kumeneku kumachokera ku Kafukufuku wa FLAMES. Kafukufukuyu ndi kafukufuku wachipatala wa gawo lachitatu, wosawoneka bwino, wolamulidwa ndi placebo, wa malo ambiri, kuti awone momwe Senaparib imagwirira ntchito ngati monotherapy yothandizira odwala omwe ali ndi khansa ya m'chiberekero yomwe idapitilira patsogolo omwe adamaliza mankhwala oyamba a chemotherapy ndipo adapeza yankho lathunthu (CR) kapena yankho laling'ono (PR). Zotsatira za Kafukufuku wa FLAMES zidawonetsa kuti Senaparib idawonetsa kusintha kwakukulu mu PFS yapakati poyerekeza ndi placebo (PFS sinafike poyerekeza ndi miyezi 13.6, HR 0.43, P < 0.0001), mosasamala kanthu za momwe BRCA ilili. Senaparib idawonetsa mbiri yachitetezo yovomerezeka, popanda mavuto owoneka bwino achitetezo. [1] Zotsatira zake zidawonetsanso kuti anthu onse omwe ali ndi HRD komanso omwe alibe HRD adapeza phindu kuchokera ku chithandizo chosamalira cha Senaparib, zomwe zikuwonetsa kuthekera kwa Senaparib kugwiritsa ntchito kuchipatala kwakukulu. Zotsatira za kafukufukuyu zithandizira kwambiri Senaparib ngati Standard of Care yothandizira odwala omwe angopezeka ndi khansa ya m'chiberekero kumene.

Zotsatira zapamwamba za kafukufukuyu poyamba zinaperekedwa ngati ulaliki womaliza pakamwa ku ESMO mu 2023 ndipo zinaperekedwa ku CSCO 2024. Pa Meyi 15, 2024, magazini yodziwika bwino ya zamankhwala padziko lonse lapansi ya Nature Medicine inafalitsanso zotsatira zake zomwe zinali ndi mutu wakuti “Senaparib as first-line maintenance therapy in advanced ovarian cancer: a randomized phase 3 trial.”

Khansa ya m'chiberekero ndi imodzi mwa khansa yoopsa kwambiri yoberekera kwa akazi. Malinga ndi deta ya GLOBOCAN 2020, kuchuluka kwa khansa ya m'chiberekero padziko lonse lapansi ndi 310,000 ndipo imfa ndi 210,000. Malinga ndi ziwerengero zaposachedwa za khansa za dziko lonse zomwe zatulutsidwa ndi National Cancer Center mu 2024, panali milandu yatsopano 61,100 ya khansa ya m'chiberekero ndi imfa 32,600 ku China mu 2022, zomwe zimapangitsa kuti ikhale chotupa choopsa kwambiri cha amayi. Chifukwa cha zizindikiro zoyambirira za khansa ya m'chiberekero, pafupifupi 80% ya odwala amakhala kale pamlingo wapamwamba akapezeka, ndipo chiŵerengero cha kupulumuka kwa zaka 5 ndi 41.8% yokha. Ngakhale khansa ya m'chiberekero ikhoza kuthetsedwa pambuyo pa chemotherapy yoyamba yokhala ndi platinum, odwala ambiri amakumana ndi kubwereranso, ndipo pakadalibe kufunikira kwakukulu kwachipatala kwa chithandizo mwa odwala khansa ya m'chiberekero.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

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Zolemba

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