Kua Pānuitia e HUTCHMED te Whakaaetanga Ā-NMPA mō te TAZVERIK® (tazemetostat) hei Maimoatanga mō te Lymphoma Follicular kua Hoki, kua Whakaroa rānei

I te 21 o Poutū-te-rangi, 2025, e kī ana kua whakaaetia te Tono Rongoā Hou ("NDA") mō TAZVERIK® (tazemetostat) i Haina mō te maimoatanga o ngā tūroro pakeke me te lymphoma follicular ("FL") kua hoki mai, kua ātete rānei ki te mate ("R/R") me te whakarerekētanga EZH2 kua whiwhi i te iti rawa e rua ngā maimoatanga pūnaha o mua. E whai ana tēnei whakaaetanga i te mana arotake matua e te Whakahaere Hua Hauora ā-Motu ("NMPA"), ā, koia te whakaaetanga ture tuatahi ā-motu mō TAZVERIK® i Haina.

I tautokona te whakaaetanga ā-ture e te NMPA e ngā hua mai i tētahi rangahau honohono Wāhanga II, maha-pokapū, tuwhera-tapanga, i Haina, me ngā rangahau haumanu i whakahaerehia e Epizyme, Inc. (“Epizyme”), he kamupene Ipsen, i waho o Haina. Ko te whāinga matua o te rangahau honohono ko te aromatawai i te reiti urupare whāinga (“ORR”) o TAZVERIK® mō te maimoatanga o ngā tūroro he R/R FL kei roto i te mate ngā whakarerekētanga EZH2. Ko ngā whāinga tuarua ko te roa o te urupare (“DoR”), te oranga kore-haere whakamua (PFS), me te oranga whānui (OS) o TAZVERIK® mō te maimoatanga o ngā tūroro R/R FL, me te aromatawai i te haumaru me te pharmacokinetics. Ka kitea ētahi atu taipitopito i clinicaltrials.gov, mā te whakamahi i te tohu tautuhi.NCT05467943.

Ko TAZVERIK® te tuatahi o ngā rongoā aukati methyltransferase o EZH2 i whakawhanakehia e Epizyme. Kua whakaaetia e te US Food and Drug Administration (“FDA”) mō te rongoā i ētahi tūroro me te R/R FL me ētahi tūroro me te epithelioid sarcoma matatau (“ES”) i raro i te kaupapa whakaae tere a te FDA. Kua whakaaetia hoki e te Manatū Hauora, Mahi me te Oranga o Hapani (MHLW) mō ētahi tūroro me te R/R FL.

Ko te Tazemetostat he aukati methyltransferase kua tohua ki te United States mo te maimoatanga o:

Kāore e tika ana kia tangohia katoatia ngā pakeke me ngā tamariki 16 tau te pakeke, neke atu rānei, me te ES kua horapa ki te pūtau, kua whanake rānei ki te rohe.

Ko ngā tūroro pakeke he R/R FL kei roto i ō rātou pukupuku he whakarerekētanga EZH2 i kitea i roto i tētahi whakamātautau kua whakaaetia e te FDA, ā, kua whiwhi i te iti rawa e rua ngā maimoatanga pūnaha o mua.

Ngā tūroro pakeke me te R/R FL kāore nei he huarahi maimoatanga kē atu e pai ana.

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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和黄医药 (hutch-med.com)