The FDA has granted full approval to the cell therapy afamitresgene autoleucel (Tecelra) for adults and children aged 12 years and older with unresectable or metastatic synovial sarcoma. The approval expands on the drug’s accelerated approval in August 2024 by adding adolescent patients to the eligible population.
The treatment is intended for patients whose cancer has progressed after prior chemotherapy and whose tumors meet specific biomarker requirements, including HLA-A*02 positivity and expression of the MAGE-A4 antigen.
The approval is supported by results from the SPEARHEAD-1 clinical trial. Among treated patients, the overall response rate was 43.8%, including a complete response rate of 3.6%. Responses were durable for some patients, with a median duration of response of 5.3 months. Nearly one-third of patients who responded to treatment maintained their response for at least two years.
The decision provides a new treatment option for patients with advanced synovial sarcoma, a rare and aggressive soft tissue cancer with limited therapeutic choices.
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