The U.S. Food and Drug Administration (FDA) has approved Tecelra (afamitresgene autoleucel or afami-cel) for the treatment of unresectable or metastatic synovial sarcoma in adults with certain HLA types who have received prior chemotherapy.

Synovial sarcoma is a rare and aggressive soft tissue sarcoma. As the tumor grows larger, affected people may notice a lump or swelling. In some cases, the tumor can limit range of motion or cause numbness and pain if it presses on nearby nerves. Although synovial sarcoma does not have a clearly defined cause, genetic factors are believed to influence the development of this disease. Cells in these tumors are usually characterized by the presence of a translocation involving chromosomes X and 18.

Afami-cel is a melanoma-associated antigen A4-directed genetically modified autologous T cell immunotherapy. It is indicated in adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy and are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive.

The approval is based on results from the SPEARHEAD-1 clinical trial testing the efficacy of afami-cel. The trial is a Phase 2, open-label, non-randomized study. The primary outcome measure was overall response rate, which was observed as 43% with a complete response rate of 4.5%. The average duration of response was six months, with 39% having a duration of response of 12 months or longer. Results from the SPEARHEAD-1 trial were recently published in The Lancet

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