I-HUTCHMED Ivakalisa Ukuvunywa Okunemiqathango kwe-NMPA kwe-TAZVERIK® (tazemetostat) yoNyango lwe-Relapsed okanye Refractory Follicular Lymphoma

Ngomhla wama-21 kuMatshi 2025, ibhengeza ukuba iSicelo seMithi emitsha (“NDA”) seTAZVERIK® (tazemetostat) sinikwe imvume emiselweyo eTshayina yokunyanga izigulane zabantu abadala abane-relapse okanye refractory (“R/R”) follicular lymphoma (“FL”) abane-EZH2 mutation abaye bafumana ubuncinane unyango lwenkqubo ezimbini zangaphambili. Olu vunyiwe lulandela imeko yokuhlolwa kwangaphambili yiNational Medical Products Administration (“NMPA”) kwaye luphawula imvume yokuqala yomthetho kazwelonke yeTAZVERIK® eTshayina.

Ukuvunywa okunemiqathango yi-NMPA kuxhaswe ziziphumo ezivela kuphando lwe-multicenter, open-label, lwe-Phase II bridging eTshayina, kunye nezifundo zeklinikhi ezenziwe yi-Epizyme, Inc. (“Epizyme”), inkampani ye-Ipsen, ngaphandle kweTshayina. Injongo ephambili yophando lwe-bridging kukuvavanya izinga lokuphendula elijolise ngqo (“ORR”) le-TAZVERIK® kunyango lwezigulane ezine-R/R FL ezinesifo sazo esine-EZH2 mutations. Iinjongo zesibini ziquka ubude bempendulo (“DoR”), ukusinda okungenankqubela phambili (PFS), kunye nokusinda ngokubanzi (OS) kwe-TAZVERIK® kunyango lwezigulane ezine-R/R FL, kunye nokuvavanya ukhuseleko kunye ne-pharmacokinetics. Iinkcukacha ezongezelelweyo zingafumaneka kwi-clinicaltrials.gov, usebenzisa isazisi.NCT05467943.

I-TAVERIK® sisithinteli se-methyltransferase sokuqala kwi-EZH2 esenziwe yi-Epizyme. Ivunyiwe yi-US Food and Drug Administration (“FDA”) ukunyanga izigulana ezithile ezine-R/R FL kunye nezigulana ezithile ezine-epithelioid sarcoma ephucukileyo (“ES”) phantsi kwenkqubo yokwamkelwa ngokukhawuleza ye-FDA. Ivunyiwe yi-Japan Ministry of Health, Labour and Welfare (MHLW) kwizigulana ezithile ezine-R/R FL.

I-Tazemetostat sisithinteli se-methyltransferase esiboniswe eMelika kunyango lwe:

Abantu abadala kunye nezigulana zabantwana abaneminyaka eli-16 nangaphezulu abane-ES eguqukileyo okanye eyenzeke kwindawo ethile abafanelekanga ukususwa ngokupheleleyo.

Izigulane zabantu abadala ezine-R/R FL ezineethumba ezifunyenwe zine-EZH2 mutation njengoko zifunyenwe luvavanyo oluvunyiweyo yi-FDA kwaye ezifumene ubuncinane unyango oluphindwe kabini ngaphambili.

Izigulane zabantu abadala abane-R/R FL abangenazo ezinye iindlela zonyango ezanelisayo.

Okwangoku, kusekho iimvavanyo ezininzi zeklinikhi zobuchwepheshe obutsha bokulwa nomhlaza eTshayina obufuna izigulane. Iingcebiso ngamayeza amatsha kunye nobuchwepheshe, ungaqhagamshelana neSebe leMicimbi yeZibhedlele ze-Oncology zaseBeijing South Region.

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Iireferensi

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