TECELRA® (afamitresgene autoleucel)

The FDA on August 2, 2024, granted accelerated approval to TECELRA®, a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma 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. TECELRA® is a product of Adaptimmune, LLC.