FDA Approves Afami-cel in Metastatic Synovial Sarcoma

The FDA has granted full approval to afamitresgene autoleucel (afami-cel; Tecelra) for patients 12 years and older who have received prior chemotherapy for unresectable or metastatic synovial sarcoma that is HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and harbors MAGE-A4 antigen expression, according to a press release from US WorldMeds.¹

The approval was supported by data from cohorts 1 to 3 from the phase 2 SPEARHEAD-1 study (NCT04044768), which assessed the agent among 137 patients. Treatment with afami-cel produced an overall response rate (ORR) of 43.8%, which included complete responses in 3.6%. Additionally, the median duration of response (DOR) was 5.3 months (95% CI, 4.5-8.2), and 31.9% of responders had sustained their response for at least 24 months.

The agent includes a safety warning for potential fever, chills or shivering, difficulty breathing, fast or irregular heartbeat, low blood pressure, and fatigue, among others.

The FDA previously granted accelerated approval to afami-cel for adult patients with metastatic or unresectable synovial sarcoma in August 2024.²

“For children as young as 12 with advanced synovial sarcoma, treatment options have been limited and navigating care decisions can be challenging. The availability of an engineered cell therapy for adolescents introduces an important new option for patients who are biomarker eligible, allowing us to incorporate this approach into treatment planning based on the same evidence that has guided adult care. This is a meaningful step forward for the field,” Amy Armstrong, MD, an associate professor of pediatrics at Washington University School of Medicine in St. Louis and director of the Solid Tumor Program at Siteman Kids at St. Louis Children's Hospital, stated in the press release.¹

References

1. US WorldMeds® receives full U.S. FDA approval of TECELRA® (afamitresgene autoleucel) with an expanded indication, extending the first approved engineered T-cell therapy for a solid tumor to children as young as 12. News release. US WorldMeds. June 22, 2026. Accessed June 22, 2026. https://tinyurl.com/33mww2su
2. Adaptimmune receives U.S. FDA accelerated approval of TECELRA® (afamitresgene autoleucel), the first approved engineered cell therapy for a solid tumor. News release. Adaptimmune Therapeutics. August 2, 2024. Accessed June 22, 2026. https://tinyurl.com/mw6k4hjh