FDA Grants Full Approval to Afami-Cel for Patients With Synovial Sarcoma by Madaline Spencer| Published on: Jun 30, 2026

https://checkrare.com/fda-grants-full-approval-to-afami-cel-for-patients-with-synovial-sarcoma/ The US Food and Drug Administration (FDA) has granted full approval to Tecelra (afamitresgene autoleucel; afami-cel) and expanded its indication to include patients ages 12 years and older with unresectable or metastatic synovial sarcoma whose disease has progressed after chemotherapy. Eligible patients must be positive for HLA-A*02:01, -A*02:02, -A*02:03, or -A*02:06 and have tumors that express the MAGE-A4 antigen.