FDA Approved ‘First Gene Therapy’ to Treat Adults with Metastatic Synovial Sarcoma

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On Aug. 2, 2024, the U.S. Food and Drug Administration approved Adaptimmune’s Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA antigen(s) A02:01P, -A02:02P, -A02:03P, or -A02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA authorized companion diagnostic devices.

Synovial sarcoma is a rare form of cancer in which malignant cells develop and form a tumor in soft tissues of the body. Each year, synovial sarcoma impacts about 1,000 people in the U.S. and most often occurs in adult males in their 30s or younger.

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