Posted by Michael Wonder on 02 Aug 2024
FDA approves first gene therapy to treat adults with metastatic synovial sarcoma
2 August 2024 - The US FDA approved Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA antigen(s) A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and whose tumour expresses the MAGE-A4 antigen as determined by FDA authorised companion diagnostic devices.
Tecelra is also the first FDA-approved T cell receptor (TCR) gene therapy.
