FDA approves afamitresgene autoleucel for advanced synovial sarcoma

The FDA granted accelerated approval to afamitresgene autoleucel, sold as TECELRA, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy. Patients must have one of the specified HLA-A*02 alleles and tumors that express the MAGE-A4 antigen. The treatment is a genetically modified autologous T cell immunotherapy.

The FDA based its decision on SPEARHEAD-1, Cohort 1. Among 44 patients who received an infusion, the overall response rate was 43.2%, and median duration of response was 6 months. The prescribing information carries a boxed warning for serious or fatal cytokine release syndrome. The FDA and the sponsor agreed on an ongoing postmarketing study to verify clinical benefit.