I-Tecelra (afamitresgene autoleucel), ukwelashwa kofuzo kokwelapha abantu abadala abane-metastatic synovial sarcoma kuvunywe FDA. Ukugunyazwa bekusekelwe ekuhlolweni kokuphepha nempumelelo esivivinyweni somtholampilo esinezikhungo eziningi, esinelebula evulekile. Yisamukeli sokuqala samaseli we-T esigunyazwe yi-FDA (TCR) i-gene therapy.
Ilawulwa njengomthamo owodwa we-IV, i-Tecelra iyi-autologous T cell immunotherapy eyenziwe ngamaseli T esiguli uqobo alungiswayo ukuze aveze i-TCR eqondise i-MAGE-A4 antigen evezwa amaseli omdlavuza ku-synovial sarcoma.
Isicanucanu, ukuhlanza, ukukhathala, izifo, imfiva, ukuqunjelwa, ukuphelelwa umoya, ubuhlungu besisu, ubuhlungu besifuba obungeyona eyenhliziyo, ukuncipha kwesifiso sokudla, ukushaya kwenhliziyo okusheshayo, ubuhlungu beqolo, umfutho wegazi ophakeme, isifo sohudo nokuvuvukala kuyizimo ezivame kakhulu zokungezwani ezihambisana nalokhu kwelashwa. Isiguli singase sibe nohlobo oluyingozi lokusabela kwamasosha omzimba futhi singase sibonise i-Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS). Ngakho, iziguli ezithola lokhu kwelashwa kufanele ziqashelwe futhi zelulekwe ukuthi zingashayeli noma zihlanganyele emisebenzini eyingozi okungenani amasonto amane ngemva kokuthola i-Tecelra.
I-Synovial sarcoma iwuhlobo olungavamile lwe umdlavuza lapho amangqamuzana ayingozi ekhula khona futhi akhe isimila ezicutshini ezithambile. Ingenzeka ezingxenyeni eziningi zomzimba, ngokuvamile ikhula emaphethelweni. Kungumdlavuza ongase ube sengozini yokuphila futhi unomthelela omubi kubantu ngabanye. Unyaka ngamunye, i-synovial sarcoma ithinta abantu abangaba ngu-1,000 e-US futhi ngokuvamile ivela kwabesilisa abadala abaneminyaka engu-30 noma ngaphansi.
Ukwelashwa ngokuvamile kuhilela ukuhlinzwa ukuze kukhishwe isimila futhi kungase kuhlanganise i-radiotherapy kanye/noma i-chemotherapy. Ukugunyazwa kwe-Tecelra kunikeza inketho entsha kubantu abathintekile abavame ukubhekana nezinketho zokwelashwa ezinomkhawulo.
Ukugunyazwa kwe-Tecelra kunikezwe i-Adaptimmune, LLC.
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References:
- I-FDA Igunyaza Ukwelashwa Kofuzo Lokuqala Ukwelapha Abantu Abadala Nge-Metastatic Synovial Sarcoma. Kushicilelwe 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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