Kua whakaaetia a Senaparib e te NMPA mō te 1L Maimoatanga Tiaki i te Mate Pukupuku Ovarian

I te 16 o Hānuere, 2025, ka pānuitia e IMPACT kua whiwhi a Senaparib Capsules (派舒宁®) i te whakaaetanga hokohoko i Haina mai i te National Medical Products Administration (NMPA) hei rongoā kotahi mō ngā tūroro pakeke e pangia ana e te mate pukupuku ovarian, te ngongo fallopian, te mate pukupuku peritoneal tuatahi rānei kua pāngia e te mate pukupuku epithelial matatau (FIGO Stages III me te IV) e tere ana te mate pukupuku ovarian, te ngongo fallopian, te mate pukupuku peritoneal tuatahi rānei, ā, kei te whakautu (katoa, wāhanga rānei) whai muri i te otinga o te chemotherapy platinum-based tuatahi.

Ko Senaparib, i kitea, i whakawhanakehia hoki e IMPACT, he aukati PARP 1/2 kaha, hou hoki. Nā tōna hanganga ngota motuhake ka nui te mahi in vitro me in vivo, he whiringa whāinga tino pai, me te matapihi haumaru whānui. Ko te whakaaetanga i ahu mai i te Rangahau FLAMES. He rangahau haumanu matapōkere, matapo-rua, whakahaere-placebo, maha-pokapū, wāhanga III tēnei rangahau hei aromatawai i te whai huatanga me te haumaru o Senaparib hei monotherapy mō te maimoatanga pupuri o ngā tūroro mate pukupuku ovarian matatau kua oti te chemotherapy raina tuatahi, ā, kua tutuki he urupare katoa (CR) he urupare wāhanga rānei (PR). I whakaatuhia e ngā hua o te Rangahau FLAMES i whakaatu a Senaparib i te whakapainga nui i roto i te PFS toharite ki te placebo (kāore i tae te PFS vs 13.6 marama, HR 0.43, P < 0.0001), ahakoa te mana BRCA. I whakaatuhia e Senaparib he kōtaha haumaru e taea ana te whakamanawanui, me te kore he take haumaru e kitea ana. [1] I whakaatuhia hoki e ngā hua i whai hua ngā taupori HRD pai me HRD kino mai i te maimoatanga pupuri Senaparib, e whakaatu ana i te kaha o Senaparib mō te tono haumanu whānui. Ka tautoko kaha ngā hua o tēnei rangahau i a Senaparib hei Paerewa Tiaki mō te rongoā tiaki tuatahi mō ngā tūroro kua kitea houtia he mate pukupuku whatukuhu.

I te tuatahi i whakaaturia ngā hua matua o te rangahau hei whakaaturanga ā-waha i te ESMO i te tau 2023, ā, i whakaaturia ki CSCO 2024. I te 15 o Mei, 2024, i whakaputahia hoki e te hautaka hauora rongonui o te ao, a Nature Medicine, ngā hua i tapaina ko "Senaparib hei rongoā tiaki raina tuatahi mō te mate pukupuku ovarian matatau: he whakamātautau wāhanga 3 matapōkere."

Ko te mate pukupuku ovarian tētahi o ngā mate pukupuku whānau wahine tino noa. E ai ki ngā raraunga a GLOBOCAN 2020, ko te maha o ngā mate pukupuku ovarian puta noa i te ao e 310,000 ngā keehi, ā, ko te mate e 210,000. E ai ki ngā tatauranga mate pukupuku ā-motu hou i tukuna e te National Cancer Center i te tau 2024, e 61,100 ngā keehi hou o te mate pukupuku ovarian me te 32,600 ngā mate i Haina i te tau 2022, koia te pukupuku wahine tino whakamate. Nā te mea he iti noa ngā tohu tōmua o te mate pukupuku ovarian, tata ki te 80% o ngā tūroro kua tae kē ki te wāhanga matatau ina kitea, ā, ko te reiti oranga 5-tau he 41.8% noa iho. Ahakoa ka taea te whakaora i te mate pukupuku ovarian i muri i te chemotherapy tuatahi kei roto te platinum, he maha ngā tūroro ka hoki anō ki te mate, ā, kei te noho tonu he hiahia nui mō te maimoatanga i roto i te taupori tūroro mate pukupuku ovarian.

I tēnei wā, he maha tonu ngā whakamātautau haumanu o ngā hangarau hou hei ārai i te matepukupuku i Haina e rapu ana i ngā tūroro. Mēnā kei te hiahia koe ki te kōrero mō ngā rongoā me ngā hangarau hou, ka taea e koe te whakapā atu ki te Tari Ao o te Hōhipera Oncology Rohe Tonga o Beijing.

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Ngā Tohutoro

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