Tecelra (afamitresgene autoleucel), unyango lwemfuza kunyango lwabantu abadala abane-metastatic synovial sarcoma luvunyiwe yi- FDA. Ukwamkelwa kwakusekelwe kuvavanyo lokhuseleko kunye nokusebenza kumaziko amaninzi, ulingo lwekliniki oluvulekileyo. Yeyokuqala i-FDA evunyiweyo ye-T cell receptor (TCR) unyango lwemfuza.
Ilawulwa njengedosi enye ye-IV, i-Tecelra yi-autologous T cell immunotherapy eyenziwe ngeeseli ze-T zesigulana eziguqulwayo ukuze zibonise i-TCR ejolise kwi-antigen ye-MAGE-A4 ebonakaliswa ngamaseli omhlaza kwi-synovial sarcoma.
Isicaphucaphu, ukugabha, ukudinwa, usulelo, umkhuhlane, ukuqhina, ukuphefumla nzima, iintlungu zesisu, iintlungu zesifuba ezingezizo ezentliziyo, ukuncipha kokutya, ukubetha kwentliziyo ngokukhawuleza, iintlungu zomqolo, hypotension, urhudo kunye nokudumba zezona zinto zixhaphakileyo ziziphumo ezibi ezinxulunyaniswa nolu nyango. Isigulana sinokufumana uhlobo oluyingozi lwempendulo ye-immune immune system kwaye sinokubonisa i-Immune Effective Cell-associated Neurotoxicity Syndrome (ICANS). Ngenxa yoko, izigulane ezifumana olu nyango kufuneka zibekwe esweni kwaye ziyacetyiswa ukuba zingaqhubeki okanye zibandakanyeke kwimisebenzi eyingozi ubuncinane kwiiveki ezine emva kokufumana iTecelra.
I-Synovial sarcoma yindlela enqabileyo ye umhlaza apho iiseli ezinobungozi zikhula kwaye zenze i-tumor kwizicubu ezithambileyo. Inokuthi yenzeke kwiindawo ezininzi zomzimba, ngokuqhelekileyo ziphuhliswa kwimida. Ngumhlaza onokubeka ubomi esichengeni kwaye unempembelelo embi ebantwini. Nyaka ngamnye, i-synovial sarcoma ichaphazela malunga ne-1,000 yabantu base-US kwaye idla ngokubakho kumadoda amadala kwiminyaka engama-30 okanye ngaphantsi.
Unyango lubandakanya utyando lokususa ithumba kwaye lusenokubandakanya iradiotherapy kunye/okanye ichemotherapy. Ukuvunywa kweTecelra kunika inketho entsha kubantu abachaphazelekayo abasoloko bejongana neendlela zonyango ezilinganiselweyo.
Imvume yeTecelra inikwe iAdaptimmune, LLC.
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Iingxelo:
- I-FDA ivuma unyango lweGene yokuQala ukuNyanga abantu abadala nge-Metastatic Synovial Sarcoma. Ipapashwe nge-02 Agasti 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}