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AUGUST 31, 2024

FDA Grants Accelerated Approval to Tecelra for Unresectable or Metastatic Synovial Sarcoma


Originally published by our sister publication Clinical Oncology News

The FDA has granted accelerated approval to afamitresgene autoleucel (Tecelra, Adaptimmune LLC), 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