Musi wa21 Kurume, 2025, yakazivisa kuti New Drug Application (“NDA”) yeTAZVERIK® (tazemetostat) yakapihwa mvumo muChina yekurapa varwere vakuru vane relapse or refractory (“R/R”) follicular lymphoma (“FL”) vane EZH2 mutation avo vakagamuchira kanenge kaviri kurapwa kwesystemic kare. Kubvumidzwa uku kunotevera mamiriro ekuongorora kwekutanga neNational Medical Products Administration (“NMPA”) uye kunoratidza mvumo yekutanga yenyika yeTAZVERIK® muChina.
Kubvumidzwa kweNMPA kwakatsigirwa nemhedzisiro yeongororo yekubatanidza masero akawanda, yakavhurika, Phase II muChina, uye zvidzidzo zvekiriniki zvakaitwa neEpizyme, Inc. ("Epizyme"), kambani yeIpsen, kunze kweChina. Chinangwa chikuru cheongororo yekubatanidza masero ndechekuongorora chiyero chekupindura chakanangana ("ORR") cheTAZVERIK® pakurapa varwere vane R/R FL vane chirwere chine EZH2 mutations. Zvinangwa zvechipiri zvaisanganisira nguva yekupindura ("DoR"), kupona kusina progression (PFS), uye kupona kwese (OS) kweTAZVERIK® pakurapa varwere veR/R FL, pamwe nekuongorora kuchengetedzeka uye pharmacokinetics. Mamwe mashoko anogona kuwanikwa pa clinicaltrials.gov, uchishandisa identifier.NCT05467943.
TAVERIK® mushonga wekutanga weEZH2 unodzivirira methyltransferase wakagadzirwa neEpizyme. Unotenderwa neUS Food and Drug Administration ("FDA") kurapa vamwe varwere vane R/R FL nevamwe varwere vane advanced epithelioid sarcoma ("ES") pasi pechirongwa cheFDA chekukurumidza kubvumidzwa. Unotenderwawo neJapan Ministry of Health, Labour and Welfare (MHLW) kune vamwe varwere vane R/R FL.
Tazemetostat inhibitor yemethyltransferase inoratidzwa muUnited States pakurapa:
Vakuru nevana vane makore gumi nematanhatu zvichikwira vane chirwere che ES chakapararira kana kuti chemunzvimbo yavo havakodzeri kubviswa chibereko zvachose.
Varwere vakuru vane R/R FL vane bundu rine EZH2 mutation sezvakaonekwa nebvunzo yakatenderwa neFDA uye vakamborapwa kaviri kare.
Varwere vakuru vane R/R FL vasina dzimwe nzira dzinogutsa dzekurapa.
Parizvino, kuchine miedzo yakawanda yekiriniki yehunyanzvi hutsva hwekurwisa gomarara muChina huri kutsvaga varwere. Kana muchida kubvunzana nezvemishonga mitsva netekinoroji, munogona kubata Dhipatimendi reBeijing South Region Oncology Hospital International.
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Mareferensi
Nguva yekutumira: Kurume-25-2025