![](https://voice.ons.org//sites/default/files/2020-05/FDA-Update-700_11_6.jpg)
FDA Grants Accelerated Approval to Afamitresgene Autoleucel for Unresectable or Metastatic Synovial Sarcoma
On August 2, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to afamitresgene autoleucel (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.