FDA Approves Engineered Cell Therapy for Advanced Synovial Sarcoma - National Cancer Institute
FDA approved afami-cel, a T-cell receptor therapy, for metastatic synovial sarcoma. It uses genetically engineered T cells to target MAGE-A4 protein in cancer cells, showing tumor shrinkage in 43% of patients with a median response duration of 6 months. Similar to CAR T-cell therapies, it addresses a high need for new treatments in this rare cancer.
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OncLive On Air podcast discusses FDA approval of afamitresgene autoleucel (afami-cel) for advanced synovial sarcoma, supported by Adaptimmune Therapeutics. Dr. Allison Betof Warner, Stanford University, highlights SPEARHEAD-1 trial results and multidisciplinary collaboration in cell therapy administration.
FDA approved afami-cel, a T-cell receptor therapy, for metastatic synovial sarcoma. It uses genetically engineered T cells to target MAGE-A4 protein in cancer cells, showing tumor shrinkage in 43% of patients with a median response duration of 6 months. Similar to CAR T-cell therapies, it addresses a high need for new treatments in this rare cancer.
FDA grants accelerated approval for Tecelra (afamitresgene autoleucel) cell therapy for treating adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy and meet specific HLA and MAGE-A4 antigen criteria. This marks the first engineered cell therapy for a solid tumor cancer approved in the U.S. and the first new therapy option in over a decade for synovial sarcoma.