Tecelra Wins Full FDA Approval, Expands to Pediatric Synovial Sarcoma

The FDA converted afamitresgene autoleucel (Tecelra, US WorldMeds) from accelerated to full traditional approval and expanded its indication to include patients as young as 12 years old, extending the world's first approved engineered T-cell therapy for a solid tumor to adolescents. Tecelra is approved for HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P-positive patients with unresectable or metastatic, MAGE-A4-expressing synovial sarcoma who have received prior chemotherapy. The conversion to full approval was supported by confirmatory data from the SPEARHEAD-1 study, in which the autologous T-cell therapy shrank tumors in roughly 44% of the 137 treated patients, with some achieving complete responses and multi-year survival.