Life Sciences Intelligence August 2, 2024
Tecelra gained FDA approval for the treatment of unresectable or metastatic synovial sarcoma.
The United States Food and Drug Administration approved Tecelra, afamitresgene autoleucel, as a new gene therapy for unresectable or metastatic synovial sarcoma. More specifically, the treatment is intended for patients who have received prior chemotherapy, have tumors that express the MAGE-A4 antigen, and are HLA antigen(s) A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive.
“Potentially life-threatening cancers such as synovial sarcoma continue to have a devastating impact on individuals, especially those for whom standard treatments have limited efficacy due to tumor growth and progression,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “The approval of this state-of-the-art immunotherapy technology provides a...
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