HUTCHMED yatangaje ko NMPA yemereye TAVERIK® (tazemetostat) kuvura indwara ya follicular lymphoma yasubiwemo cyangwa yasubiwemo

Ku ya 21 Werurwe 2025, yatangaje ko Porogaramu nshya y'imiti ("NDA") kuri TAVERIK® (tazemetostat) yemerewe mu Bushinwa kuvura abarwayi bakuru bafite indwara yo kurwara indwara ya follicular lymphoma ("FL") yasubiwemo cyangwa yasubitswe (“R/R”) bafite EZH2 mutation bamaze nibura ubuvuzi bubiri bwabanje. Iyi nyandiko ikurikira isuzuma ry’ibanze ryakozwe n’Ikigo cy’Igihugu gishinzwe Ibikoresho by’Ubuvuzi ("NMPA"), ikaba ari yo nyandiko ya mbere yemewe mu gihugu hose kuri TAVERIK® mu Bushinwa.

Kwemezwa kwa NMPA byashyigikiwe n'ibyavuye mu bushakashatsi bwakozwe mu Bushinwa mu bigo byinshi, bufunguye, icyiciro cya kabiri cy'ubuhuza mu bushinwa, n'ubushakashatsi bwakozwe na Epizyme, Inc. (“Epizyme”), ikigo cya Ipsen, hanze y'Ubushinwa. Intego nyamukuru y'ubushakashatsi bwa businganya ni ugusuzuma igipimo cy'ubuhuza ("ORR") cya TAVERIK® mu kuvura abarwayi ba R/R FL bafite indwara ya EZH2 mutations. Intego z'inyongera zari zirimo igihe cyo gusubiza ("DoR"), kubaho nta guhindagurika (PFS), no kubaho muri rusange (OS) kwa TAVERIK® mu kuvura abarwayi ba R/R FL, ndetse no gusuzuma umutekano n'imiti. Ibisobanuro birambuye biboneka kuri clinicaltrials.gov, ukoresheje identifier.NCT05467943.

TAVERIK® ni umuti wa mbere wo mu rwego rwo hejuru ugabanya ubukana bwa EZH2 wakozwe na Epizyme. Wemejwe n'Ikigo gishinzwe ibiribwa n'imiti muri Amerika (“FDA”) mu kuvura abarwayi bamwe na bamwe bafite indwara ya R/R FL n'abarwayi bamwe na bamwe bafite indwara ya epithelioid sarcoma (“ES”) muri gahunda yo kwemeza yihutishijwe na FDA. Wemejwe kandi na Minisiteri y'Ubuzima, Umurimo n'Imibereho Myiza y'Abayapani (MHLW) ku barwayi bamwe na bamwe bafite indwara ya R/R FL.

Tazemetostat ni umuti ubuza methyltransferase wagaragajwe muri Leta Zunze Ubumwe za Amerika mu kuvura:

Abantu bakuru n'abana bafite imyaka 16 kuzamura bafite ES ya metastatic cyangwa ES yateye imbere mu gace runaka ntibashobora kubagwa burundu.

Abarwayi bakuru barwaye R/R FL bafite ibibyimba byagaragaye ko bafite EZH2 mutation nk'uko byagaragaye mu isuzuma ryemewe na FDA kandi bakaba barahawe nibura ubuvuzi bubiri mbere.

Abarwayi bakuru bafite uburwayi bwa R/R FL badafite ubundi buryo bwiza bwo kuvura.

Kugeza ubu, haracyari igeragezwa ryinshi ry’ikoranabuhanga rishya rirwanya kanseri mu Bushinwa rishaka abarwayi. Inama ku miti mishya n’ikoranabuhanga, ushobora kuvugana n’Ishami Mpuzamahanga ry’Ibitaro bya Oncology bya Beijing mu Karere k’Amajyepfo.

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Amareferensi

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