TECELRA Wins Full FDA Approval With Expanded Synovial Sarcoma Indication

June 22, 2026 at 12:28

USWM CT, LLC (US WorldMeds) announced that the FDA granted full approval to afamitresgene autoleucel (TECELRA, US WorldMeds) and expanded its indication to include pediatric patients aged 12 years and older with unresectable or metastatic synovial sarcoma. TECELRA became the first engineered T-cell therapy for a solid tumor to receive accelerated FDA approval in the US in August 2024.

The therapy is indicated for adult and pediatric patients aged 12 years and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, HLA-A*02:02P, HLA-A*02:03P, or HLA-A*02:06P positive, and whose tumors express the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. TECELRA is administered as a single intravenous infusion.

The full approval and expanded indication were based on results from Cohorts 1, 2, and 3 of SPEARHEAD-1, an open-label, single-arm clinical study. The trial enrolled 171 patients who underwent leukapheresis; 137 received a single infusion of TECELRA and were included in the efficacy analysis. The major efficacy outcome was overall response rate (ORR) determined by an independent review committee. Duration of response was an additional efficacy outcome.

Treatment with TECELRA produced an ORR of 43.8%, including a complete response rate of 3.6%. The median duration of response was 5.3 months (95% CI, 4.5-8.2). Based on the Kaplan-Meier method, an estimated 31.9% of patients who responded to treatment had a response lasting at least 24 months.

TECELRA is made from a patient’s own white blood cells, which are genetically modified to recognize and attack cancer cells. Patients must be monitored daily at a health care facility for at least 7 days after infusion and remain near a health care facility for at least 2 weeks.