Posted by Michael Wonder on 23 Jun 2026
US WorldMeds receives full US FDA approval of Tecelra (afamitresgene autoleucel) with an expanded indication, extending the first approved engineered T-cell therapy for a solid tumour to children as young as 12
22 June 2026 - US WorldMeds announced that the US FDA has granted full approval of Tecelra (afamitresgene autoleucel) and expanded its indication to include pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.
Administered as a single infusion, Tecelra became the first engineered T-cell therapy for a solid tumor cancer to receive accelerated FDA approval in the US, granted in August 2024.
