Official announcements from Adaptimmune or the acquiring company

FDA Grants Accelerated Approval to Adaptimmune's TECELRA, First Engineered Cell Therapy for Solid Tumor

Aug 2, 2024, 09:45 AM

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Adaptimmune's TECELRA® (afamitresgene autoleucel), marking the first approved engineered cell therapy for a solid tumor. This gene therapy is indicated for the treatment of adults with unresectable or metastatic synovial sarcoma, a rare form of cancer that develops in the soft tissues of the body. The approval represents a significant milestone for the oncology community, extending the power of immunotherapies into difficult-to-reach sarcomas. Patients eligible for this treatment must have tumors expressing MAGE-A4 and be positive for HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P.