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FDA Grants Accelerated Approval to Afamitresgene Autoleucel for Synovial Sarcoma

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Emedinexus    30 May 2025

FDA granted accelerated approval to afamitresgene autoleucel, a genetically modified autologous T cell therapy targeting MAGE-A4, for adults with unresectable or metastatic synovial sarcoma. Eligible patients must have received prior chemotherapy, be HLA-A02:01P, -A02:02P, -A02:03P, or -A02:06P positive, and have tumors expressing the MAGE-A4 antigen as confirmed by an FDA-approved diagnostic test.

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