FDA Fully Approves T-Cell Therapy for Advanced Synovial Sarcoma

The FDA has granted full approval to afamitresgene autoleucel (afami-cel), an engineered T-cell therapy, for adult and pediatric patients with unresectable or metastatic synovial sarcoma. This treatment is for those who have received prior chemotherapy and meet specific genetic criteria. The decision was supported by data from the SPEARHEAD-1 trial, expanding on an earlier accelerated approval.