Tecelra (afamitresgene autoleucel), he lāʻau lapaʻau no ka mālama ʻana i nā pākeke me ka metastatic synovial sarcoma ua ʻae ʻia e ka FDA. Hoʻokumu ʻia ka ʻae ʻia ma luna o ka loiloi o ka palekana a me ka pono i loko o kahi multicentre, open-label clinical trials. ʻO ia ka mea mua loa i ʻae ʻia e ka FDA T cell receptor (TCR) hoʻōla gen.
Hoʻohana ʻia ʻo Tecelra ma ke ʻano he hoʻokahi pānaʻi IV, ʻo Tecelra kahi autologous T cell immunotherapy i hana ʻia me nā cell T ponoʻī o ka mea maʻi i hoʻololi ʻia e hōʻike i kahi TCR e kuhikuhi ana i ka antigen MAGE-A4 i hōʻike ʻia e nā maʻi maʻi maʻi i ka synovial sarcoma.
ʻO ka nausea, ka luaʻi, ka luhi, nā maʻi, ke kuni, ka paʻa, ka pōkole o ka hanu, ka ʻeha ʻōpū, ka ʻeha o ka umauma puʻuwai ʻole, ka emi ʻana o ka ʻai, ka wikiwiki o ka naʻau, ka ʻeha hope, hypotension, diarrhea a me ka pehu ʻana nā hopena ʻino loa e pili ana i kēia lapaʻau. Hiki i ka maʻi ke loaʻa i kahi ʻano pōʻino o ka pane ʻana o ka ʻōnaehana pale kino a hōʻike pū paha i ka Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS). No laila, pono e nānā ʻia nā poʻe maʻi e loaʻa ana i kēia lāʻau lapaʻau a ʻōlelo ʻia ʻaʻole e hoʻokele a hana i nā hana pōʻino no ka liʻiliʻi o ʻehā pule ma hope o ka loaʻa ʻana o Tecelra.
ʻO Synovial sarcoma kahi ʻano kakaʻikahi o Ka maʻi 'aʻai kahi e ulu ai a hoʻokumu ʻia nā pūpū ʻino i loko o nā ʻiʻo palupalu. Hiki ke loaʻa ma nā wahi he nui o ke kino, ka mea maʻamau e ulu ana ma nā ʻoki. He maʻi maʻi ʻino ia e hoʻoweliweli i ke ola a loaʻa ka hopena pōʻino i nā kānaka. I kēlā me kēia makahiki, pili ka synovial sarcoma ma kahi o 1,000 poʻe ma US a loaʻa pinepine i nā kāne makua ma ko lākou mau makahiki 30 a ʻoi paha.
Hoʻohana maʻamau ka lāʻau lapaʻau no ka wehe ʻana i ka ʻōpū a hiki ke hoʻokomo pū ʻia me ka radiotherapy a/a i ʻole ka chemotherapy. Hāʻawi ka ʻae ʻana iā Tecelra i kahi koho hou no ka poʻe i hoʻopilikia pinepine ʻia i nā koho lapaʻau liʻiliʻi.
Ua hāʻawi ʻia ka ʻae ʻana o Tecelra iā Adaptimmune, LLC.
***
E hoʻomaopopo ':
- Ua ʻae ʻo FDA i ka lāʻau lapaʻau mua e mālama i nā pākeke me ka Metastatic Synovial Sarcoma. Paʻi ʻia 02 ʻAukake 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treat-adults-metastatic-synovial-sarcoma
***
, 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}