Tecelra (afamitresgene autoleucel), kev kho noob rau kev kho cov neeg laus nrog metastatic synovial sarcoma tau pom zoo los ntawm FDA. Qhov kev pom zoo yog raws li kev soj ntsuam ntawm kev nyab xeeb thiab kev ua tau zoo hauv ntau qhov chaw, qhib-label kuaj sim. Nws yog thawj zaug FDA pom zoo T cell receptor (TCR) noob kev kho.
Kev tswj hwm raws li ib koob tshuaj IV, Tecelra yog ib qho autologous T cell immunotherapy ua los ntawm tus neeg mob tus kheej T hlwb uas tau hloov kho los qhia txog TCR uas tsom rau MAGE-A4 antigen qhia los ntawm cov qog nqaij hlav hauv synovial sarcoma.
xeev siab, ntuav, qaug zog, kis kab mob, ua npaws, cem quav, ua tsis taus pa, mob plab, tsis mob hauv siab, tsis qab los noj mov, plawv dhia ceev, mob nraub qaum, hypotension, raws plab thiab o yog qhov tshwm sim tsis zoo uas cuam tshuam nrog kev kho mob no. Tus neeg mob yuav ntsib ib yam txaus ntshai ntawm kev tiv thaiv kab mob tiv thaiv kab mob thiab kuj tseem tuaj yeem ua rau muaj qhov tshwm sim ntawm Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS). Yog li ntawd, cov neeg mob uas tau txais kev kho mob no yuav tsum tau saib xyuas thiab qhia kom tsis txhob tsav tsheb lossis koom nrog kev ua phem rau tsawg kawg plaub lub lis piam tom qab tau txais Tecelra.
Synovial sarcoma yog ib hom tsis tshua muaj cancer nyob rau hauv uas malignant hlwb tsim thiab tsim ib tug qog nyob rau hauv cov ntaub so ntswg mos. Nws tuaj yeem tshwm sim hauv ntau qhov chaw ntawm lub cev, feem ntau tshwm sim hauv cov extremities. Nws yog ib qho mob qog noj ntshav uas muaj peev xwm ua rau muaj sia nyob thiab muaj kev cuam tshuam loj heev rau tib neeg. Txhua xyoo, synovial sarcoma cuam tshuam txog 1,000 tus neeg hauv Asmeskas thiab feem ntau tshwm sim rau cov txiv neej laus hauv lawv 30s lossis hluas dua.
Kev kho mob feem ntau suav nrog kev phais kom tshem tawm cov qog thiab kuj tseem tuaj yeem suav nrog kev kho hluav taws xob thiab / lossis tshuaj khomob. Kev pom zoo ntawm Tecelra muab ib qho kev xaiv tshiab rau cov neeg cuam tshuam uas feem ntau ntsib cov kev xaiv kho mob tsawg.
Kev pom zoo ntawm Tecelra tau tso cai rau Adaptimmune, LLC.
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References:
- FDA Pom Zoo Thawj Kev Kho Mob los kho cov neeg laus nrog Metastatic Synovial Sarcoma. Luam tawm Lub Yim Hli 02, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treat-adults-metastatic-synovial-sarcoma
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, a gene therapy for the treatment of adults with metastatic synovial sarcoma has been approved by the FDA. The approval was based on assessment of safety and effectiveness in a multicentre, open-label clinical trial. It is the first FDA-approved T cell receptor (TCR) gene therapy.){kind=link}