FDA Fully Approves Afami-Cel for Synovial Sarcoma, Expands Use to Adolescents

The U.S. FDA has granted full approval for afamitresgene autoleucel (afami-cel), an engineered T-cell therapy, for unresectable or metastatic synovial sarcoma. This decision converts its prior accelerated approval and expands its use to include pediatric patients aged 12 and older. Afami-cel is now the first engineered T-cell therapy for a solid tumor approved for adolescents in the U.S., offering a new option for eligible patients who have received prior chemotherapy.