TECELRA
STN: 125789
Proper Name: afamitresgene autoleucel
Tradename: TECELRA
Manufacturer: Adaptimmune LLC
Indication:
- Treatment of adults and pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLAA* 02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGEA4 antigen as determined by FDA-approved or cleared companion diagnostic devices.
Product Information
Supporting Documents
- June 17, 2026 Approval Letter - TECELRA
- August 1, 2024 Approval Letter - TECELRA
- August 1, 2024 Summary Basis for Regulatory Action - TECELRA
- Letters, Reviews, Related Documents - TECELRA