I-HUTCHMED Imemezela Ukuvunyelwa Okunemibandela kwe-NMPA kwe-TAVERIK® (tazemetostat) Yokwelapha i-Relapsed noma i-Refractory Follicular Lymphoma

NgoMashi 21, 2025, imemezela ukuthi i-New Drug Application (“NDA”) ye-TAVERIK® (tazemetostat) inikezwe imvume enemibandela eShayina yokwelapha iziguli ezindala ezine-relapse or refractory (“R/R”) follicular lymphoma (“FL”) ene-EZH2 mutation ezithole okungenani izindlela zokwelapha ezimbili zangaphambilini. Lokhu kuvunyelwa kulandela isimo sokubuyekezwa okubalulekile yi-National Medical Products Administration (“NMPA”) futhi kuphawula imvume yokuqala yokulawula kazwelonke ye-TAVERIK® eShayina.

Ukuvunyelwa okunemibandela yi-NMPA kwasekelwa yimiphumela evela ocwaningweni lwe-multicenter, olwe-open-label, lwe-Phase II bridging eShayina, kanye nezifundo zezokwelapha ezenziwe yi-Epizyme, Inc. (“Epizyme”), inkampani ye-Ipsen, ngaphandle kweShayina. Inhloso eyinhloko yocwaningo lwe-bridging ukuhlola izinga lokuphendula eliqondile (“ORR”) le-TAZVERIK® lokwelapha iziguli ezine-R/R FL ezinesifo sazo esinezinguquko ze-EZH2. Izinhloso zesibili zazihlanganisa ubude besikhathi sempendulo (“DoR”), ukusinda okungenalo ukuqhubekela phambili (PFS), kanye nokusinda okuphelele (OS) kwe-TAZVERIK® ekwelapheni iziguli ze-R/R FL, kanye nokuhlola ukuphepha kanye ne-pharmacokinetics. Imininingwane eyengeziwe ingatholakala ku-clinicaltrials.gov, kusetshenziswa isihlonzi.I-NCT05467943.

I-TAVERIK® iyi-inhibitor yokuqala ye-methyltransferase ye-EZH2 eyenziwe yi-Epizyme. Ivunyiwe yi-US Food and Drug Administration (“FDA”) yokwelapha iziguli ezithile ezine-R/R FL kanye neziguli ezithile ezine-epithelioid sarcoma ethuthukisiwe (“ES”) ngaphansi kohlelo lokuvunywa olusheshisiwe lwe-FDA. Ivunyiwe futhi yi-Japan Ministry of Health, Labour and Welfare (MHLW) yeziguli ezithile ezine-R/R FL.

I-Tazemetostat iyi-methyltransferase inhibitor ekhonjisiwe e-United States ekwelapheni:

Abantu abadala kanye neziguli zezingane ezineminyaka engu-16 nangaphezulu ezine-ES esakazekile noma ethuthukisiwe endaweni azifaneleki ukuhlinzwa ngokuphelele.

Iziguli ezindala ezine-R/R FL ezinezimila ezitholakala zine-EZH2 mutation njengoba kutholakale ngokuhlolwa okuvunyelwe yi-FDA futhi ezithole okungenani izindlela zokwelapha zomzimba ezimbili ngaphambilini.

Iziguli ezindala ezine-R/R FL ezingenazo ezinye izindlela zokwelapha ezanelisayo.

Njengamanje, kusenezivivinyo eziningi zemitholampilo zobuchwepheshe obusha bokulwa nomdlavuza eShayina ezifuna iziguli. Ukubonisana ngemithi emisha kanye nobuchwepheshe, ungaxhumana noMnyango Wezizwe Ngezizwe Wesibhedlela iBeijing South Region Oncology.

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