FDA Grants Full Approval for Afami-Cel Therapy, Expanding Use for Synovial Sarcoma Patients

The U.S. Food and Drug Administration has granted full approval for afamitresgene autoleucel, an engineered T-cell therapy for unresectable or metastatic synovial sarcoma. This decision converts its prior accelerated approval and broadens its use to include pediatric patients aged 12 and older. It marks the first engineered T-cell therapy for a solid tumor to be approved for adolescents in the United States.