Adaptimmune Therapeutics has received FDA accelerated approval for Tecelra (afamitresgene autoleucel), a gene therapy to treat certain cases of synovial sarcoma in adults. Tecelra is the first engineered cell therapy for a solid tumor cancer approved in the US and the first new therapy option for synovial sarcoma in over a decade.

Tecelra is an autologous T-cell immunotherapy that targets MAGE-A4, an antigen expressed by cancer cells in synovial sarcoma. It uses a patient's immune cells to recognize and attack cancer cells via a one-time infusion. The therapy is indicated for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-positive, and whose tumor expresses the MAGE-A4 antigen.

The approval was based on results from the SPEARHEAD-1 trial, which showed an overall response rate of 43% and a complete response rate of 4.5%. Adaptimmune plans to run 6–10 authorized treatment centers this year and about 30 centers within two years. The company has also launched AdaptimmuneAssist, an integrated support program for patients and healthcare providers throughout the Tecelra treatment journey.

Adaptimmune is focused on developing engineered T-cell therapies to treat solid tumor cancers. The company's proprietary SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.