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.
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 |