HUTCHMED mara ọkwa nkwenye NMPA maka TAZVERIK® (tazemetostat) maka ọgwụgwọ nke Lymphoma follicular nke na-agbanwe agbanwe ma ọ bụ nke na-adịghị ike.

Na Machị 21, 2025, kwupụtara na enyerela ikike maka ojiji ọgwụ ọhụrụ ("NDA") maka TAZVERIK® (tazemetostat) na China maka ọgwụgwọ ndị okenye nwere ọrịa lymphoma follicular nke na-alọghachi azụ ma ọ bụ nke na-adịghị ike ("R/R") (FL) nwere mgbanwe EZH2 bụ ndị natara ma ọ dịkarịa ala ọgwụgwọ usoro abụọ gara aga. Nkwenye a na-esochi ọkwa nyocha mbụ nke National Medical Products Administration ("NMPA") ma na-egosi nkwenye iwu mba niile maka TAZVERIK® na China.

Nkwenye ọnọdụ nke NMPA nwetara site na nsonaazụ sitere na ọmụmụ ihe njikọta nke Phase II na China, nke nwere ọtụtụ etiti, na-emeghe, na ọmụmụ ihe gbasara ahụike nke Epizyme, Inc. (“Epizyme”), ụlọ ọrụ Ipsen, na mpụga China mere. Isi ihe mgbaru ọsọ nke ọmụmụ njikọta bụ inyocha ọnụego nzaghachi ebumnuche (“ORR”) nke TAZVERIK® maka ọgwụgwọ nke ndị ọrịa nwere R/R FL nke ọrịa ha nwere mgbanwe EZH2. Ebumnuche nke abụọ gụnyere oge nzaghachi ("DoR"), ndụ na-enweghị ọganihu (PFS), na ndụ zuru oke (OS) nke TAZVERIK® maka ọgwụgwọ nke ndị ọrịa R/R FL, yana inyocha nchekwa na pharmacokinetics. Enwere ike ịchọta nkọwa ndị ọzọ na clinicaltrials.gov, site na iji njirimaraNCT05467943.

TAZVERIK® bụ ọgwụ mgbochi methyltransferase nke mbụ nke EZH2 nke Epizyme mepụtara. US Food and Drug Administration ("FDA") kwadoro ya maka ọgwụgwọ nke ụfọdụ ndị ọrịa nwere R/R FL na ụfọdụ ndị ọrịa nwere nnukwu epithelioid sarcoma ("ES") n'okpuru mmemme nkwado ngwa ngwa nke FDA. Ngalaba Ahụike, Ọrụ na Ọdịmma Japan (MHLW) na-akwadokwa ya maka ụfọdụ ndị ọrịa nwere R/R FL.

Tazemetostat bụ ọgwụ mgbochi methyltransferase nke egosiri na United States maka ọgwụgwọ nke:

Ndị okenye na ụmụaka dị afọ iri na isii na karịa nwere ọrịa ES ma ọ bụ nke dị elu n'ógbè ha erughị eru maka ịwa ahụ zuru oke.

Ndị ọrịa toro eto nwere R/R FL bụ ndị etuto ahụ ha dị mma maka mgbanwe EZH2 dịka a chọpụtara site na ule FDA kwadoro, ndị natara ọgwụgwọ sistemụ ugboro abụọ gara aga.

Ndị ọrịa toro eto nwere R/R FL bụ ndị na-enweghị nhọrọ ọgwụgwọ ọzọ dị mma.

Ugbu a, enwere ọtụtụ nnwale ahụike nke teknụzụ ọhụrụ na-egbochi kansa na China na-achọ ndị ọrịa. Maka ndụmọdụ gbasara ọgwụ na teknụzụ ọhụrụ, ị nwere ike ịkpọtụrụ Ngalaba Mba Nile nke Ụlọ Ọgwụ Oncology nke Beijing South Region.

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和黄医药 (hutch-med.com)