Hoʻolaha ʻo HUTCHMED i ka ʻae ʻia ʻana o ka NMPA no TAZVERIK® (tazemetostat) no ka mālama ʻana i ka Lymphoma Follicular Relapsed a Refractory paha

Ma Malaki 21, 2025, hoʻolaha ʻia ua hāʻawi ʻia ka New Drug Application ("NDA") no TAZVERIK® (tazemetostat) i ka ʻae ʻia ma Kina no ka mālama ʻana i nā maʻi makua me ka relapsed a refractory ("R/R") follicular lymphoma ("FL") me ka EZH2 mutation i loaʻa i ʻelua mau lāʻau lapaʻau mua. Ma hope o kēia ʻae ʻia ke kūlana loiloi koʻikoʻi e ka National Medical Products Administration ("NMPA") a hōʻailona i ka ʻae mua ʻana o ka hoʻoponopono aupuni no TAZVERIK® ma Kina.

Ua kākoʻo ʻia ka ʻae ʻia ʻana e ka NMPA e nā hopena mai kahi noiʻi hoʻopili ʻana o ka Phase II ma Kina, a me nā noiʻi lapaʻau i mālama ʻia e Epizyme, Inc. ("Epizyme"), he hui Ipsen, ma waho o Kina. ʻO ka pahuhopu nui o ke aʻo ʻana i ka hoʻopili ʻana, ʻo ia ka loiloi ʻana i ka helu pane kūpono ("ORR") o TAZVERIK® no ka mālama ʻana i nā maʻi me R/R FL nona ka maʻi e loaʻa ana nā hoʻololi EZH2. ʻO nā pahuhopu lua e komo pū ana me ka lōʻihi o ka pane ("DoR"), ke ola ʻole o ka holomua (PFS), a me ke ola holoʻokoʻa (OS) o TAZVERIK® no ka mālama ʻana i nā maʻi R/R FL, a me ka loiloi ʻana i ka palekana a me ka pharmacokinetics. Hiki ke loaʻa nā kikoʻī hou aku ma clinicaltrials.gov, me ka hoʻohana ʻana i ka mea hōʻike.NCT05467943.

ʻO TAZVERIK® kahi mea hoʻopaʻa methyltransferase mua loa o EZH2 i hoʻomohala ʻia e Epizyme. Ua ʻāpono ʻia e ka US Food and Drug Administration ("FDA") no ka mālama ʻana i kekahi mau maʻi me R/R FL a me kekahi mau maʻi me ka epithelioid sarcoma holomua ("ES") ma lalo o ka papahana ʻāpono wikiwiki ʻia e ka FDA. Ua ʻāpono ʻia hoʻi e ke Kuhina Ola, Hana a me ka Pono o Iapana (MHLW) no kekahi mau maʻi me R/R FL.

ʻO Tazemetostat kahi mea hoʻopaʻa methyltransferase i hōʻike ʻia ma ʻAmelika Hui Pū ʻIa no ka mālama ʻana i:

ʻAʻole kūpono nā pākeke a me nā keiki i piha i nā makahiki 16 a ʻoi me ka ES metastatic a i ʻole ka ES holomua kūloko no ka resection piha.

ʻO nā poʻe maʻi makua me R/R FL nona nā puʻupuʻu i loaʻa ka hopena no kahi hoʻololi EZH2 e like me ka mea i ʻike ʻia e kahi hoʻokolohua i ʻāpono ʻia e ka FDA a ua loaʻa iā lākou ma ka liʻiliʻi he ʻelua mau lāʻau lapaʻau mua.

Nā poʻe maʻi makua me R/R FL ʻaʻohe o lākou mau koho lapaʻau ʻē aʻe kūpono.

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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