Thaum Lub Peb Hlis 21, 2025, tshaj tawm tias Daim Ntawv Thov Tshuaj Tshiab ("NDA") rau TAZVERIK® (tazemetostat) tau txais kev pom zoo hauv Suav teb rau kev kho mob rau cov neeg laus uas rov qab mob lossis tsis kho tau ("R/R") follicular lymphoma ("FL") nrog EZH2 mutation uas tau txais tsawg kawg yog ob txoj kev kho mob ua ntej. Kev pom zoo no ua raws li qhov xwm txheej tshuaj xyuas tseem ceeb los ntawm National Medical Products Administration ("NMPA") thiab cim thawj qhov kev pom zoo thoob tebchaws rau TAZVERIK® hauv Suav teb.
Qhov kev pom zoo los ntawm NMPA tau txais kev txhawb nqa los ntawm cov txiaj ntsig los ntawm kev tshawb fawb txog ntau lub chaw, qhib daim ntawv lo, Theem II hauv Suav teb, thiab kev tshawb fawb hauv tsev kho mob uas Epizyme, Inc. ("Epizyme"), ib lub tuam txhab Ipsen, ua sab nraum Suav teb. Lub hom phiaj tseem ceeb ntawm kev tshawb fawb txog kev sib txuas lus yog los ntsuam xyuas qhov kev teb sai ("ORR") ntawm TAZVERIK® rau kev kho mob ntawm cov neeg mob uas muaj R/R FL uas muaj kab mob EZH2 mutations. Lub hom phiaj thib ob suav nrog lub sijhawm teb ("DoR"), kev ciaj sia tsis muaj kev nce qib (PFS), thiab kev ciaj sia tag nrho (OS) ntawm TAZVERIK® rau kev kho mob ntawm cov neeg mob R/R FL, nrog rau kev ntsuam xyuas kev nyab xeeb thiab pharmacokinetics. Cov ntsiab lus ntxiv tuaj yeem pom ntawm clinicaltrials.gov, siv tus cim qhia.NCT05467943.
TAZVERIK® yog thawj tus neeg sawv cev methyltransferase inhibitor ntawm EZH2 uas tsim los ntawm Epizyme. Nws tau txais kev pom zoo los ntawm US Food and Drug Administration ("FDA") rau kev kho mob rau qee tus neeg mob uas muaj R/R FL thiab qee tus neeg mob uas muaj epithelioid sarcoma ("ES") raws li FDA qhov kev pom zoo sai. Nws kuj tau txais kev pom zoo los ntawm Japan Ministry of Health, Labour and Welfare (MHLW) rau qee tus neeg mob uas muaj R/R FL.
Tazemetostat yog ib qho tshuaj methyltransferase inhibitor uas tau qhia nyob rau hauv Tebchaws Meskas rau kev kho mob ntawm:
Cov neeg laus thiab cov menyuam yaus hnub nyoog 16 xyoo thiab laus dua uas muaj mob qog nqaij hlav metastatic lossis mob qog nqaij hlav hauv zos tsis tsim nyog phais tag nrho.
Cov neeg mob laus uas muaj R/R FL uas lawv cov qog nqaij hlav muaj qhov hloov pauv EZH2 raws li pom los ntawm kev kuaj mob uas FDA pom zoo thiab uas tau txais tsawg kawg yog ob txoj kev kho mob thoob plaws lub cev ua ntej.
Cov neeg laus uas muaj R/R FL uas tsis muaj lwm txoj kev kho mob zoo.
Tam sim no, tseem muaj ntau qhov kev sim tshuaj kho mob qog noj ntshav tshiab hauv Suav teb nrhiav cov neeg mob. Kev sab laj txog cov tshuaj tshiab thiab cov thev naus laus zis, koj tuaj yeem tiv tauj Beijing South Region Oncology Hospital International Department.
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Lub sijhawm tshaj tawm: Lub Peb Hlis-25-2025