FDA Activity Recap: August 2024 Features TCR T-Cell Therapy Approval, REMS ...
In August 2024, the FDA approved Adaptimmune Therapeutics’ afami-cel for synovial sarcoma, modified REMS for CAR-T therapies, lifted a hold on 4D Molecular Therapeutics’ Fabry disease gene therapy, provided guidance for IN8bio’s INB-100 in AML, and cleared Biosyngen’s BRG01 for a pivotal trial in EBV-positive nasopharyngeal carcinoma.
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Fabry diseaseBiosyngenAbecmaIN8bioTecartusNCT04519749KymriahYescarta4D Molecular TherapeuticsAdaptimmune TherapeuticsMemorial Sloan Kettering Cancer CenterNCT03533816CarvyktiBreyanzisynovial sarcomaafami-celINB-100acute myeloid leukemia4D-310Epstein-Barr virus-positive relapsed/metastatic nasopharyngeal carcinomaBRG01FDA
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FDA Activity Recap: August 2024 Features TCR T-Cell Therapy Approval, REMS ...
In August 2024, the FDA approved Adaptimmune Therapeutics’ afami-cel for synovial sarcoma, modified REMS for CAR-T therapies, lifted a hold on 4D Molecular Therapeutics’ Fabry disease gene therapy, provided guidance for IN8bio’s INB-100 in AML, and cleared Biosyngen’s BRG01 for a pivotal trial in EBV-positive nasopharyngeal carcinoma.