TECELRA  (Afamitresgene autoleucel)

TECELRA (afamitresgene autoleucel) is a melanoma-associated antigen A4 (MAGEA4)-directed genetically modified autologous T cell immunotherapy product consisting of CD4 and CD8 positive T cells transduced with a self-inactivating lentiviral vector (LV) expressing an affinity-enhanced T cell receptor (TCR) specific for the human MAGE-A4. Autologous T cells transduced with MAGE-A4-c1032 LV express the affinity-enhanced TCR on the cell surface. The TCR recognizes an HLA-A*02 restricted MAGE-A4 peptide. MAGE-A4 is an intracellular cancer-testis antigen that has restricted expression in normal tissues and is expressed in synovial sarcoma. TECELRA was approved by the U.S. Food and Drug Administration (FDA) on August 1, 2024 for the treatment of adults with unresectable or metastatic SyS who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Synovial sarcoma (SyS) is a rare, aggressive soft tissue sarcoma that can occur in many parts of the body but most commonly develops in the extremities. Each year, SyS affects about 1000 people in the United States. Treatment of SyS typically involves surgery to remove the tumor and may also include radiotherapy or chemotherapy if the tumor is larger, returns after being removed, or has spread beyond its original location. <a id="