Afamitresgene autoleucel is an engineered T-cell therapy — reportedly the first engineered cell therapy approved for a solid tumor in the United States — that received accelerated approval based on…
Afamitresgene autoleucel is an engineered T-cell therapy — reportedly the first engineered cell therapy approved for a solid tumor in the United States — that received accelerated approval based on…
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Last reviewed
FDA Approvals
Regulatory approval is separate from evidence certainty and from guideline position. Approval applies only to the exact indication stated in each jurisdiction record.
Adults (later reportedly expanded to include patients age 12 and older) with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P, and whose tumor is confirmed MAGE-A4-positive by an FDA-approved or cleared companion diagnostic — a genetically restricted population; only a minority of synovial sarcoma patients meet both the HLA and MAGE-A4 requirements. Efficacy reported here is from the 44-patient efficacy-evaluable analysis within a 52-patient enrolled cohort (SPEARHEAD-1 Cohort 1).
View approval details
Last reviewed
2026-08-13
Regulatory status by jurisdiction
United States (FDA)
Status
FDA-approved for the exact stated cancer/use
Indication
Adults 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 an FDA-approved or cleared companion diagnostic device.
Biomarker requirement
HLA-A*02 (specific subtypes) and MAGE-A4 tumor expression
Decision date
2024-08-01
Access notes
Accelerated approval — continued approval was contingent on confirmatory trial data at the time of this approval.
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