2024 Biological License Application Approvals

This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval.

2024 Biological License Application Approvals">2024 Biological License Application Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License Number
Approval Date
TECELRA
afamitresgene autoleucel
Indicated for treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. 125789/0 Adaptimmune LLC
351 Rouse Boulevard
Philadelphia, PA 19112