HUTCHMED Yalengeza Kuvomerezedwa kwa NMPA kwa TAZVERIK® (tazemetostat) Pochiza Matenda a Follicular Lymphoma Obwereranso Kapena Osakhazikika

Pa Marichi 21, 2025, yalengeza kuti New Drug Application (“NDA”) ya TAVERIK® (tazemetostat) yavomerezedwa ku China kuti ithandize odwala akuluakulu omwe ali ndi matenda obwereranso kapena osagwirizana ndi matenda (“R/R”) follicular lymphoma (“FL”) omwe ali ndi kusintha kwa EZH2 omwe adalandira chithandizo chamankhwala chamthupi kawiri m'mbuyomu. Chilolezochi chikutsatira momwe bungwe la National Medical Products Administration (“NMPA”) linaneneratu kuti TAVERIK® ndi yoyamba kuvomerezedwa ndi boma ku China.

Kuvomerezedwa kokhazikika ndi NMPA kunathandizidwa ndi zotsatira za kafukufuku wokhudza kutseka kwa phase II ku China, komanso maphunziro azachipatala omwe adachitika ndi Epizyme, Inc. ("Epizyme"), kampani ya Ipsen, kunja kwa China. Cholinga chachikulu cha kafukufuku wotseka ndikuwunika kuchuluka kwa mayankho ("ORR") a TAVERIK® pochiza odwala omwe ali ndi R/R FL omwe matenda awo ali ndi kusintha kwa EZH2. Zolinga zachiwiri zinali nthawi yoyankha ("DoR"), kupulumuka kopanda kupita patsogolo (PFS), ndi kupulumuka konse (OS) kwa TAVERIK® pochiza odwala a R/R FL, komanso kuwunika chitetezo ndi mankhwala. Zambiri zitha kupezeka pa clinicaltrials.gov, pogwiritsa ntchito chizindikiritso.NCT05467943.

TAVERIK® ndi mankhwala oyamba oletsa methyltransferase a EZH2 omwe adapangidwa ndi Epizyme. Avomerezedwa ndi US Food and Drug Administration (“FDA”) pochiza odwala ena omwe ali ndi R/R FL ndi odwala ena omwe ali ndi epithelioid sarcoma yapamwamba (“ES”) motsatira pulogalamu yovomerezeka ya FDA. Avomerezedwanso ndi Unduna wa Zaumoyo, Ntchito ndi Ubwino wa Anthu ku Japan (MHLW) kwa odwala ena omwe ali ndi R/R FL.

Tazemetostat ndi mankhwala oletsa methyltransferase omwe akuwonetsedwa ku United States pochiza:

Akuluakulu ndi odwala ana azaka 16 kapena kuposerapo omwe ali ndi ES yofalikira kapena yotsogola m'deralo sakuyenerera kuchitidwa opaleshoni yonse.

Odwala akuluakulu omwe ali ndi R/R FL omwe ali ndi zotupa zomwe zili ndi kusintha kwa EZH2 monga momwe zapezekera ndi mayeso ovomerezeka ndi FDA ndipo omwe adalandirapo chithandizo chamankhwala chamthupi chamthupi kawiri m'mbuyomu.

Odwala akuluakulu omwe ali ndi R/R FL omwe alibe njira zina zokhutiritsa zochiritsira.

Pakadali pano, pali mayesero ambiri azachipatala a ukadaulo watsopano wothana ndi khansa ku China omwe akufuna odwala. Mukafunsira mankhwala ndi ukadaulo watsopano, mutha kulumikizana ndi Dipatimenti Yapadziko Lonse ya Chipatala cha Oncology ku Beijing South Region.

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和黄医药 (hutch-med.com)