Ua ʻāpono ʻia ʻo Senaparib e NMPA no ka mālama ʻana i ka 1L ma ke kanesa ovarian

Ma Ianuali 16, 2025, ua hoʻolaha ʻo IMPACT ua loaʻa iā Senaparib Capsules (派舒宁®) ka ʻae kūʻai aku ma Kina mai ka National Medical Products Administration (NMPA) ma ke ʻano he monotherapy no ka mālama ʻana i nā poʻe maʻi makua me ka epithelial kiʻekiʻe (FIGO Stages III a me IV) ovarian kiʻekiʻe, fallopian tube a i ʻole ke kanesa peritoneal mua e pane ana (piha a hapa paha) ma hope o ka hoʻopau ʻana i ka chemotherapy platinum-based mua.

ʻO Senaparib, i ʻike ʻia a hoʻomohala ʻia e IMPACT, he mea hoʻopaʻa PARP 1/2 ikaika a hou. Hāʻawi kona ʻano molekala kūikawā iā ia me ka hana in vitro a me in vivo kiʻekiʻe, ke koho ʻana i ka pahuhopu kūikawā a me ka puka makani palekana ākea. Hoʻokumu ʻia ka ʻae ʻia ma ka FLAMES Study. ʻO ke aʻo ʻana he randomized, double-blind, placebo-controlled, multicenter, phase III clinical study e loiloi i ka pono a me ka palekana o Senaparib ma ke ʻano he monotherapy no ka mālama ʻana i nā maʻi me ka maʻi ʻaʻai ovarian holomua i hoʻopau i ka chemotherapy laina mua a loaʻa i kahi pane piha (CR) a i ʻole ka pane hapa (PR). Ua hōʻike nā hopena o ka FLAMES Study ua hōʻike ʻo Senaparib i ka hoʻomaikaʻi koʻikoʻi ma ka median PFS i hoʻohālikelike ʻia me ka placebo (ʻaʻole i hiki ʻo PFS vs 13.6 mau mahina, HR 0.43, P < 0.0001), me ka nānā ʻole i ke kūlana BRCA. Ua hōʻike ʻo Senaparib i kahi ʻano palekana hiki ke hoʻomanawanui ʻia, me ka ʻole o nā pilikia palekana i ʻike ʻia. [1] Ua hōʻike pū nā hopena ua loaʻa i nā heluna kanaka HRD maikaʻi a me HRD maikaʻi ʻole ka pōmaikaʻi mai ka mālama ʻana o Senaparib, e hōʻike ana i ka hiki o Senaparib no ka noi lapaʻau ākea. E kākoʻo ikaika nā hopena o kēia noiʻi iā Senaparib ma ke ʻano he Kūlana Mālama no ka mālama mālama mua ʻana i nā poʻe maʻi me ka maʻi ʻaʻai ovarian hou i ʻike ʻia.

Ua hōʻike mua ʻia nā hopena kiʻekiʻe o ke aʻo ʻana ma ke ʻano he hōʻike waha lohi ma ESMO i ka makahiki 2023 a ua hōʻike ʻia ma CSCO 2024. Ma ka lā 15 o Mei, 2024, ua paʻi pū ka puke pai lapaʻau kaulana o ka honua ʻo Nature Medicine i nā hopena i kapa ʻia ʻo "Senaparib as first-line maintenance therapy in advanced ovarian cancer: a randomized phase 3 trial."

ʻO ke kanesa ovarian kekahi o nā maʻi ʻino hānau wahine make loa. Wahi a ka ʻikepili GLOBOCAN 2020, ʻo ka nui o ka maʻi kanesa ovarian ma ka honua holoʻokoʻa he 310,000 mau hihia a ʻo ka make he 210,000. Wahi a nā helu helu kanesa aupuni hou loa i hoʻokuʻu ʻia e ka National Cancer Center i ka makahiki 2024, aia he 61,100 mau hihia hou o ke kanesa ovarian a me 32,600 mau make ma Kina i ka makahiki 2022, e lilo ia i puʻupuʻu gynecological make loa. Ma muli o nā hōʻailona mua a i ʻole kikoʻī ʻole o ke kanesa ovarian, ma kahi o 80% o nā maʻi i ke kahua holomua i ka wā i ʻike ʻia ai lākou, a ʻo ka helu ola 5 makahiki he 41.8 wale nō. ʻOiai hiki ke hoʻoponopono ʻia ke kanesa ovarian ma hope o ka chemotherapy platinum mua, ʻo ka hapa nui o nā maʻi e kū nei i ka hoʻi hou ʻana, a aia nō kahi pono lapaʻau koʻikoʻi i hoʻokō ʻole ʻia no ka mālama ʻana i ka heluna o nā maʻi kanesa ovarian.

I kēia manawa, nui nā hoʻokolohua lapaʻau o nā ʻenehana anti-cancer hou ma Kina e ʻimi nei i nā maʻi. I ke kūkākūkā ʻana i nā lāʻau lapaʻau a me nā ʻenehana hou, hiki iā ʻoe ke hoʻokaʻaʻike aku i ka Beijing South Region Oncology Hospital International Department.

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Nā Kuhikuhi

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