US WorldMeds gets full approval for Tecelra, expands access to patients aged 12+

The U.S. FDA has granted full approval to US WorldMeds’ autologous T cell immunotherapy, Tecelra, and expanded its indication to include pediatric patients 12 years of age and older.

Tecelra is approved for 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. The full FDA approval and expanded indication was based on results of the SPEARHEAD-1 study, an open-label, single-arm clinical study, which included 137 patients.

Tecelra was granted accelerated approval in August 2024 for the treatment of advanced MAGE-A4+synovial sarcoma in adults with certain HLA types who have received prior chemotherapy, marking the first new treatment for synovial sarcoma — a rare cancer that develops in soft tissues — in over a decade.

Administered as a single infusion, Tecelra was also the first engineered T-cell therapy for a solid tumor cancer to receive accelerated FDA approval in the U.S. The approval was originally granted to Adaptimmune Therapeutics, who later sold Tecelra, as well as three other cell therapies, to US WorldMeds for $55 million in cash as well as future payments of up to $30 million.