Novartis Kymriah qhov kev qhia thib peb nkag mus rau hauv Asmeskas thiab Europe

Novartis tsis ntev los no tau tshaj tawm tias US Food and Drug Administration (FDA) thiab European Medicines Agency (EMA) tau lees txais daim ntawv tso cai ntxiv cov khoom siv roj ntsha (sBLA) thiab Class II hloov rau CD19 CAR-T cell therapy Kymriah (tisagenlecleucel): Rau kev kho mob ntawm cov neeg laus cov neeg mob rov qab los yog refractory follicular lymphoma (r / r FL) uas yav tas los tau txais tsawg kawg 2 kev kho mob. FDA tau tso cai saib xyuas qhov tseem ceeb rau sBLA.

Yav dhau los, FDA tau tso cai Kymriah Cov Tshuaj Kho Mob Advanced Therapy (RMAT) rau kev kho mob ntawm r / r FL; European Commission (EC) tau tso cai Kymriah lub Orphan Drug Designation (ODD) rau kev kho mob ntawm FL. Yog tias pom zoo, Kymriah yuav muab kev kho mob tseem ceeb rau cov neeg mob r/r FL. Nyob rau tib lub sijhawm, r / r FL tseem yuav dhau los ua Kymriah' qhov thib peb qhia rau B cell malignancies.

Kymriah yog CD19-qhia kev hloov kho autologous T cell immune cell kho. Tsis zoo li cov qauv me me los yog kev kho mob lom, CAR-T cell therapy yog ib qho khoom siv kho mob T cell. Lub hauv paus ntsiab lus ntawm Kymriah yog txhawm rau hloov kho cov noob caj noob ces tus neeg mob T hlwb kom nthuav tawm chimeric antigen receptor (CAR) tsim los rau lub hom phiaj antigen CD19, uas yog ib qho antigen protein qhia rau saum npoo ntawm ntau hom qog ntshav, suav nrog B cells Lymphoma thiab leukemia hlwb.

Kymriah yog thawj CAR-T cell kho tau pom zoo los ntawm US FDA. Nws yog tam sim no nyob rau hauv kev ua lag luam nyob rau hauv 30 lub teb chaws thiab muaj ntau tshaj 345 certified chaw kho mob. Kymriah yog ib qho kev kho mob ib zaug tsim los ntxiv dag zog rau tus neeg mob' lub cev tiv thaiv kab mob los tiv thaiv qog noj ntshav. Tam sim no, Kymriah' cov kev pom zoo pom muaj xws li: (1) kev kho mob rov qab los yog refractory mob lymphoblastic leukemia (r/r ALL) cov menyuam yaus thiab cov neeg laus (hnub nyoog txog 25 xyoo); (2) Kev kho mob ntawm relapsed los yog refractory mob lymphoblastic leukemia (r / r TAG NRHO) Cov neeg laus uas muaj mob loj B-cell lymphoma (r / r DLBCL).

Daim ntawv thov qhia tshiab no yog ua raws li cov ntaub ntawv zoo ntawm qhov tseem ceeb Theem 2 ELARA mus sib hais. Qhov no yog ib sab caj npab, ntau qhov chaw, qhib-label Phase 2 sim uas ntsuas qhov ua tau zoo thiab kev nyab xeeb ntawm Kymriah hauv kev kho cov neeg laus nrog R / R FL. Cov ntaub ntawv qhia tau hais tias txoj kev tshawb fawb tau pom cov lus teb muaj zog hauv r / r FL cov neeg mob uas yav tas los tau txais ntau yam kev kho mob (nruab nrab: 4 [ntau: 2-13]): qhov ua tiav cov lus teb (CR) ntawm 66%, tag nrho cov lus teb. tus nqi (ORR) mus txog 86%. Kev nyab xeeb tseem ceeb heev. Hauv thawj 8 lub lis piam tom qab txhaj tshuaj, tsis muaj cov neeg mob uas muaj Kymriah-qib 3 lossis siab dua cytokine release syndrome (CRS). Cov ntaub ntawv sim tau tshaj tawm ua ntej xyoo no ntawm 2021 American Society of Clinical Oncology (ASCO) lub rooj sib tham txhua xyoo virtual.

Jeff Legos, Tus Lwm Thawj Coj Tus Thawj Coj thiab Tus Thawj Coj Ntiaj Teb ntawm Oncology thiab Hematology Development, Novartis, tau hais tias: "Qhov no yog lub sijhawm tseem ceeb hauv peb lub luag haujlwm los muab Kymriah rau cov neeg laus cov neeg laus uas rov qab los lossis rov qab follicular lymphoma. Tau txais daim ntawv pov thawj tshuaj kho menyuam ntsuag los ntawm EC thiab FDA qhov kev tshuaj xyuas tseem ceeb qhia txog qhov tseem ceeb ntawm cov kev xav tau thiab kev kub ntxhov hauv cov neeg mob no. Kymriah tau nthuav tawm cov txiaj ntsig zoo hauv ELARA kev sim, thiab peb cia siab tias peb tuaj yeem muab kev kho mob tshwj xeeb thiab muaj peev xwm kawg txo lub nra."