I-Senaparib Ivunyiwe yi-NMPA Yokwelashwa Kokunakekelwa Kwe-1L kumdlavuza wesibeletho

Ngomhlaka-16 Januwari 2025, i-IMPACT imemezele ukuthi ama-Senaparib Capsules (派舒宁®）athole imvume yokumaketha eShayina evela ku-National Medical Products Administration (NMPA) njengokwelashwa okukodwa kokunakekelwa kweziguli ezindala ezine-epithelial advanced (FIGO Stages III and IV) high-grade ovarian, fallopian tube noma primary peritoneal cancer ezisabela (eziphelele noma ezingaphelele) ngemuva kokuphothulwa kwe-chemotherapy yokuqala esekelwe ku-platinum.

I-Senaparib, etholakale futhi yathuthukiswa yi-IMPACT, iyisivimbeli se-PARP 1/2 esinamandla nesisha. Isakhiwo sayo esihlukile sama-molecule siyinikeza umsebenzi ophezulu we-in vitro kanye ne-in vivo, ukukhetha okuqondiwe okuhlukile kanye nefasitela lokuphepha elibanzi. Ukuvunyelwa kusekelwe ku-FLAMES Study. Lolu cwaningo luwucwaningo lwezokwelapha lwesigaba sesi-3 olungahleliwe, olungaboni kabili, olulawulwa yi-placebo, olunezikhungo eziningi, lokuhlola ukusebenza kahle kanye nokuphepha kwe-Senaparib njengokwelashwa okukodwa kokwelashwa kokunakekelwa kweziguli ezinomdlavuza we-ovarian othuthukile eziqede ukwelashwa ngamakhemikhali okuqala futhi zithole impendulo ephelele (CR) noma impendulo engaphelele (PR). Imiphumela ye-FLAMES Study ibonise ukuthi i-Senaparib ibonise ukuthuthuka okukhulu ku-PFS ephakathi uma kuqhathaniswa ne-placebo (i-PFS engafinyelelwanga vs izinyanga ezingu-13.6, i-HR 0.43, P < 0.0001), kungakhathalekile isimo se-BRCA. I-Senaparib ibonise iphrofayili yokuphepha ebekezelelekayo, ngaphandle kwezinkinga zokuphepha ezibonakalayo. [1] Imiphumela iphinde yabonisa ukuthi kokubili abantu abane-HRD kanye nabangenayo i-HRD bathola izinzuzo ekwelashweni kokugcinwa kwe-Senaparib, okugqamisa amandla e-Senaparib ekusetshenzisweni kwemitholampilo okubanzi. Imiphumela yalolu cwaningo izoyisekela kakhulu iSenaparib njengeSimiso Sokunakekelwa sokwelashwa kokugcina komugqa wokuqala ezigulini ezisanda kutholakala ukuthi zinesifo somdlavuza wesibeletho.

Imiphumela ephezulu yocwaningo yaqale yethulwa njengesethulo somlomo esiphuthuma sekwephuzile e-ESMO ngo-2023 futhi yethulwa e-CSCO 2024. Ngomhlaka-15 Meyi 2024, iphephabhuku lezokwelapha elidumile emhlabeni wonke i-Nature Medicine nalo lashicilela imiphumela enesihloko esithi “i-Senaparib njengokwelashwa kokugcina komdlavuza we-ovarian othuthukisiwe: isivivinyo sesigaba sesi-3 esingahleliwe.”

Umdlavuza wesibeletho ungomunye wemikhuhlane ebulalayo yokuzala kwabesifazane evame kakhulu. Ngokusho kwedatha ye-GLOBOCAN 2020, ukwanda komdlavuza wesibeletho emhlabeni wonke kufinyelele kumacala angu-310,000 kanti ukufa kufinyelele ku-210,000. Ngokusho kwezibalo zakamuva zomdlavuza kazwelonke ezikhishwe yiNational Cancer Center ngo-2024, kube namacala amasha angu-61,100 omdlavuza wesibeletho kanye nokufa okungu-32,600 eShayina ngo-2022, okwenza kube yisifo sabesifazane esibulalayo kakhulu. Ngenxa yezimpawu zokuqala zomdlavuza wesibeletho ezingabonakali futhi ezingaqondile, cishe ama-80% eziguli asevele esesigabeni esiphambili lapho etholakala, kanti izinga lokusinda kweminyaka emi-5 lingama-41.8% kuphela. Nakuba umdlavuza wesibeletho ungaxazululwa ngemuva kokwelashwa ngamakhemikhali okuqala aqukethe i-platinum, iziguli eziningi zibhekene nokubuyela emuva, futhi kusenesidingo esikhulu sokwelashwa esingakahlangatshezwa kubantu abanomdlavuza wesibeletho.

Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

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Izinkomba

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