Adaptimmune gets accelerated approval for Tecelra
October 2024—Adaptimmune Therapeutics announced FDA accelerated approval for Tecelra (afamitresgene autoleucel) for the 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. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent on verification and description of clinical benefit in a confirmatory trial.