Thaum lub Cuaj Hlis 6, 2021, JW Therapeutics tshaj tawm tias Lub Chaw Saib Xyuas Khoom Siv Kho Mob Hauv Tebchaws (NMPA) ntawm Tuam Tshoj tau pom zoo Daim Ntawv Thov Tshuaj Tshiab (NDA) rau nws cov tshuaj tiv thaiv CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy khoom relmacabtagene autoleucel txhaj tshuaj (relma-cel) rau kev kho mob rau cov neeg laus uas muaj mob rov qab los yog tsis kho tau loj B-cell lymphoma (r/r LBCL) tom qab ob lossis ntau kab ntawm kev kho mob systemic, thiab tau tso tawm daim ntawv pov thawj rau npe tshuaj. Relma-cel yog thawj cov khoom CAR-T tau pom zoo ua cov khoom siv biologics Qeb 1 hauv Tuam Tshoj, thiab cov khoom CAR-T thib rau tau pom zoo thoob ntiaj teb.
Txog Relmacabtagene Autoleucel Txhaj Tshuaj (lub npe lag luam: Carteyva®)
Relmacabtagene autoleucel txhaj tshuaj (luv ua relma-cel, lub npe lag luam: Carteyva) yog ib yam khoom kho mob tiv thaiv CD19 CAR-T cell immunotherapy uas JW Therapeutics tsim los ntawm lub platform CAR-T cell process ntawm Juno Therapeutics (lub tuam txhab Bristol Myers Squibb).
Qhov kev pom zoo no yog raws li cov txiaj ntsig ntawm kev tshawb fawb ib leeg, ntau lub chaw, pivotal (RELIANCE kev tshawb fawb) los ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm relma-cel rau cov neeg mob uas muaj r/r LBCL hauv Suav teb. Cov txiaj ntsig ntawm kev tshawb fawb RELIANCE qhia tau tias relma-cel tau ua pov thawj tias muaj cov kab mob teb tau zoo thiab cov kab mob CAR-T tsawg, thiab tej zaum yuav muab cov ntaub ntawv kho mob CAR-T zoo tshaj plaws.
Ntawm Lub Rooj Sib Tham Txhua Xyoo 24th ntawm Lub Koom Haum Suav Teb ntawm Kev Kho Mob Oncology (CSCO), JW Therapeutics tau tshaj tawm cov txiaj ntsig tshiab 1-xyoo ntawm kev txhaj tshuaj relmacabtagene autoleucel (relma-cel) rau kev kho mob r/r LBCL. Cov txiaj ntsig suav nrog:
Relma-cel tau qhia txog cov lus teb ruaj khov thiab cov txiaj ntsig ntawm kev ciaj sia mus ntev; Qhov Zoo Tshaj Plaws Tag Nrho Cov Lus Teb (ORR) yog 77.6%, Qhov Zoo Tshaj Plaws Tag Nrho Cov Lus Teb (CRR) yog 51.7% thiab 1-xyoo Tag Nrho Kev Ciaj Sia (OS) yog 76.8% nrog rau kev saib xyuas nruab nrab ntawm 17.9 lub hlis;
Relma-cel feem ntau tau txais kev pom zoo nrog cov ntaub ntawv kev nyab xeeb suav nrog Cytokine Release Syndrome qis qis (≥grade 3) ntawm 5.1% thiab tus nqi neurotoxicity qis qis (≥grade 3) ntawm 3.4%, thiab tsis muaj cov cim qhia kev nyab xeeb tshiab nrog rau qhov nruab nrab ntawm 17.9 lub hlis ntawm kev saib xyuas;
Kev soj ntsuam mus sij hawm ntev ntawm txoj kev tshawb fawb RELIANCE tau lees paub qhov ua tau ntev ntawm kev teb thiab OS mus sij hawm ntev nrog kev kho mob relma-cel, uas kuj tau cuam tshuam nrog cov nqi qis ntawm CAR-T-cuam tshuam kev lom.
LBCL yog hom mob lymphoma uas tshwm sim ntau tshaj plaws thiab ua rau neeg mob hnyav heev thiab feem ntau cov neeg mob rov qab mob dua tom qab kev kho mob thawj zaug nrog kev kho mob tsawg nrog kev kho mob ib txwm muaj thiab lub neej ntev li ntawm 6 lub hlis. Cov ntaub ntawv soj ntsuam ntev no tau tshaj tawm los ntawm kev tshawb fawb RELIANCE tau lees paub qhov ua tau ntev ntawm cov lus teb tom qab kev kho mob relma-cel, uas sawv cev rau kev xaiv kev kho mob tseem ceeb rau cov neeg mob no uas zoo li muaj kev cia siab meej tias yuav muaj sia nyob ntev dua.
Tam sim no, muaj ntau lwm yam kev sim tshuaj CAR-T hauv Suav teb, thiab lawv tab tom nrhiav cov neeg mob. Yog xav tau 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.
Xov Tooj: 4008803716
Email：myimmnet@163.com
Cov ntaub ntawv siv los ua piv txwv
2.https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20210903084004127.html
3.https://www.sciencedirect.com/science/article/pii/S0006497118704138
4.https://www.jwtherapeutics.com/en/media/press-release/jw-therapeutics-announces-updated-1-year-follow-up-result-of-relmacabtagene-autoleucel-injection-at-the-24th-annual-meeting-of-the-chinese-society-of-clinical-oncology-csco-1/
Lub sijhawm tshaj tawm: Kaum Ib Hlis-15-2024