I te 3 o Tīhema, 2024, kua whakaaetia te rongoā auaha a Zepzelca (lurbinectedin mō te werohanga) kia hokohokohia e te Whakahaere Hua Hauora ā-Motu o Haina (NMPA) mā te kaupapa arotake matua. Kua tohua te rongoā mō te maimoatanga o ngā tūroro pakeke e pāngia ana e te mate pukupuku pūkahukahu pūtau iti kua horapa (SCLC) me te whanaketanga o te mate i runga, i muri rānei i te chemotherapy e ahu mai ana i te konukawata.
He aukati whiriwhiri a Zepzelca i te whakawhitiwhiti oncogenic. Ahakoa e aukati ana i te whakawhitiwhiti oncogenic, ka whakahaere i te taiao moroiti mō ngā pukupuku, ā, ka arahi ki te apoptosis o ngā pūtau pukupuku. I whakaaetia hoki te rongoā e te US Food and Drug Administration (FDA) mā tana Hōtaka Whakaae Whakatere i te tau 2020. Mō ngā tau 27, koinei anake te hinonga matū hou i whakaaetia e te FDA mō te maimoatanga o te SCLC kua hoki mai mai i te tau 1997.
I runga i ngā hua o ngā rangahau haumanu e rua te whakaaetanga a te NMPA ki a Zepzelca. Ko tētahi o aua rangahau he rangahau matua i whakahaerehia ki tāwāhi, he rangahau tuwhera, he rangahau maha-pokapū, he rangahau ringa-kotahi (he whakamātautau kete Wāhanga 2) i roto i ngā tūroro pakeke me te SCLC (tae atu ki ngā tūroro tairongo-platinum me ngā tūroro ātete-platinum) i pāngia e te whanaketanga o te mate i muri i te whiwhinga chemotherapy e hangai ana ki te platinum. I roto i tēnei rangahau, i rongoatia rātou ki a Zepzelca anake mā te werohanga ā-uaua o te rongoā i ia 3 wiki i te horopeta o te 3.2 mg/m2. I whakaputaina te rangahau ki roto i te The Lancet Oncology, i whakaatu i te reiti urupare whānui (ORR) o te 35.2%, he roanga urupare waenga (mDoR) o te 5.3 marama, he oranga kore-whakahaere waenga (mPFS) o te 3.5 marama, me te mOS o te 9.3 marama mō ngā tūroro katoa i rongoatia ki a Zepzelca. Ko tētahi atu rangahau he rangahau haumanu kotahi-ringa, e hono ana i te whakanui me te whakawhānui i te horopeta mō Zepzelca hei aromatawai i tōna haumaru, tōna manawanui, ōna pharmacokinetics (PK), me tōna whai huatanga tuatahi i roto i ngā tūroro Hainamana he pukupuku totoka kua whanake, tae atu ki te SCLC e hokihoki ana. I whakaatuhia e te rangahau he ORR o te 45.5%, he mDoR o te 4.2 marama, he mPFS o te 5.6 marama me te mOS o te 11.0 marama mō ngā tūroro SCLC i rongoatia ki a Zepzelca mā te werohanga ā-uaua i ia 3 wiki i te horopeta o te 3.2 mg/m2.
I whakaatuhia e ngā rangahau e rua i runga ake nei he kaha nui ki te ārai i te pukupuku mō Zepzelca hei maimoatanga tuarua mō te SCLC me te kōtaha haumaru ka taea te whakahaere. Hei tāpiri, i whakaatuhia e te rangahau i mahia i roto i te taupori Hainamana he pai ake ngā putanga o ngā tūroro.
Hei tāpiritanga, kei te tirotirohia hoki a Zepzelca i roto i ngā whakamātautau haumanu maha o te ao. I roto i tētahi rangahau Wāhanga 1/2, i whakaatuhia e Zepzelca i te taha o te atezolizumab he ORR o te 66.67%, he mPFS o te 4.7 marama, me te mOS o te 14.5 marama i te whakamahinga hei maimoatanga raina tuarua mō ngā tūroro he SCLC wāhanga whānui. I roto i tētahi atu rangahau Wāhanga 1/2, i whakaatuhia e Zepzelca i te taha o te pembrolizumab he ORR o te 46.4%, he mPFS o te 5.3 marama, me te mOS o te 11.1 marama hei maimoatanga raina tuarua mō ngā tūroro he SCLC kua hoki anō. Hei tāpiritanga, kei te haere tonu ngā rangahau haumanu e whakauru ana i a Zepzelca i te taha o tētahi aukati ārai mate hei rongoā pupuri raina tuatahi mō te SCLC, i te taha o te chemotherapy mō te maimoatanga o te SCLC kua hoki anō, me te maimoatanga o te leiomyosarcoma. Kua hangaia ēnei rangahau hei tirotiro tonu i te tono haumanu me te kaha rongoā o te rongoā.
Tae noa ki tēnei wā, kua whakaaetia a Zepzelca mō te hokohoko i roto i ngā whenua me ngā rohe 17 o te ao. Kua whakawhiwhia a Luye Pharma ki ngā mana ki te whakawhanake me te hokohoko i tēnei rongoā i te whenua nui o Haina, i Hong Kong, me Macao, ā, kua whiwhi whakaaetanga hokohoko mō te rongoā i roto i ēnei rohe e toru.
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
1.2024年12月03日药品批准证明文件送达信息 (nmpa.gov.cn)
2.绿叶制药宣布治疗小细胞肺癌创新药赞必佳® （注射用芦比替定）获得国家药品监督管理局上市批准 – 新闻动态 – 绿叛行(luye.cn)
Wā tuku: Hanuere-14-2025