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FDA Approves Adaptimmune's Groundbreaking Gene Therapy for Rare Cancer

NextEdge Admin

02 Aug 2024

1 min 6 sec

The U.S. Food and Drug Administration (FDA) has approved Adaptimmune's gene therapy, Tecelra, for treating synovial sarcoma, a rare soft tissue cancer primarily affecting young men. This approval marks the first gene therapy in the U.S. that leverages a patient's own T-cells to combat cancer. Tecelra is intended for patients who have previously undergone chemotherapy. The treatment, delivered as a single intravenous dose, is priced at $727,000. It received accelerated approval from the FDA, which necessitates confirmation of its benefits through a subsequent trial. Synovial sarcoma, typically developing in the extremities, affects approximately 1,000 people annually in the U.S., predominantly adult males in their 30s or younger, according to the FDA.