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Afamitresgene autoleucel was the first engineered T-cell receptor therapy approved for a solid tumour, synovial sarcoma.
Afamitresgene autoleucel (afami-cel) is a TCR-T therapy: patient T cells are engineered with an affinity-enhanced T-cell receptor that recognises the MAGE-A4 230-239 peptide on HLA-A*02, so eligibility requires both HLA typing and tumour MAGE-A4 testing. It received accelerated approval in August 2024 for advanced MAGE-A4-positive, HLA-A*02-positive synovial sarcoma on SPEARHEAD-1 (ORR about 39%, median duration of response about 12 months), and in Q2 2026 the label was extended to patients aged 12 and over. Treatment is a single infusion of 2.68 to 10 x 10^9 TCR-positive cells after fludarabine and cyclophosphamide; cytokine release syndrome and prolonged cytopenias are the main risks. Whether responses are durable enough to change survival is open. For a newcomer: the first engineered T-cell receptor therapy approved for a solid tumour.
1.Patient's T cells are engineered to express an affinity-enhanced TCR recognising MAGE-A4 peptide on HLA-A*02
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
Autologous TCR-T for MAGE-A4-positive synovial sarcoma (2024); not covered by the CAR-T NCD, so coverage is contractor-determined. Inpatient administration falls under Part A.
Covered with prior authorisation and usually a single-case agreement with a certified treatment centre; many plans restrict to centres of excellence and require documentation of prior lines of therapy. HLA-A*02 and MAGE-A4 expression must be documented.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · Medicare.gov: Inpatient hospital care (Part A) · CMS Medicare Coverage Database (NCDs and LCDs). Not medical or financial advice; verify with your plan.
Sources: NICE search: afamitresgene autoleucel. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Accelerated approval, MAGE-A4+ HLA-A*02+ advanced synovial sarcoma (SPEARHEAD-1): first TCR-T for a solid tumour source
Treatment of 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 FDA-approved or cleared companion diagnostic devices.
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 2.1 years later, when the FDA's table was read. source
US rights sold by Adaptimmune to US WorldMeds source
Label extended to patients aged 12 and older source
| Region | Year | Indication |
|---|---|---|
| US | 2024 | Advanced MAGE-A4+ synovial sarcoma, HLA-A*02+ (age ≥12 from 2026) |
| Adverse event |
|---|
| Cytokine release syndrome |
| Nausea |
| Vomiting |
| Fatigue |
| Infections |
| Prolonged cytopenias |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (inpatient/outpatient); commercial per plan | $727,000 per infusion (list price at launch, 2024) | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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Query for this drug: (TITLE:"Afamitresgene autoleucel" OR ABSTRACT:"Afamitresgene autoleucel" OR TITLE:"Tecelra" OR ABSTRACT:"Tecelra" OR TITLE:"afami-cel" OR ABSTRACT:"afami-cel") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Afamitresgene autoleucel, not a curated reading list.
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