FDA Grants Full Approval to Afami-Cel for Advanced Synovial Sarcoma

The FDA has granted full approval of afamitresgene autoleucel (afami-cel; Tecelra) for the treatment of adult patients and 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.¹

The approval builds on the August 2024 accelerated approval of afami-cel, when it was initially indicated only for adult patients.²

Regular approval was supported by data from the cohorts 1, 2, and 3 of the SPEARHEAD-1 trial (NCT04044768), which demonstrated that treatment with afami-cel led to an overall response rate (ORR) of 43.8%, including a complete response rate of 3.6%.¹ The median duration of response was 5.3 months (95% CI, 4.5-8.2), and 31.9% of responders achieved a duration of response of at least 24 months.

"For children as young as 12 with advanced synovial sarcoma, treatment options have been limited and navigating care decisions can be challenging," 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 a news release. "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."

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://www.prnewswire.com/news-releases/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-tumor-to-children-as-young-as-12-302806599.html?tc=eml_cleartime
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 1, 2024. Accessed June 22, 2026. https://www.adaptimmune.com/investors-and-media/news-center/press-releases/detail/271/adaptimmune-receives-u-s-fda-accelerated-approval-of