Afamitresgene autoleucel
Afamitresgene autoleucel was the first engineered T-cell receptor therapy approved for a solid tumour, synovial sarcoma.
Accelerated approval August 2024 (SPEARHEAD-1: ORR ~39%, median DOR ~12 months) for MAGE-A4+ HLA-A*02+ synovial sarcoma; Q2 2026 label includes patients aged 12+. Adaptimmune divested US rights to US WorldMeds in 2025.
1.Patient's T cells are engineered to express an affinity-enhanced TCR recognising MAGE-A4 peptide on HLA-A*02
- Route
- Single IV infusion after lymphodepletion
- Schedule
- 2.68 × 10⁹ to 10 × 10⁹ MAGE-A4 TCR+ T cells; fludarabine 30 mg/m² ×4 and cyclophosphamide 600 mg/m² ×3
- Dose modifications
- Tocilizumab/steroids for CRS
- Monitoring
- Daily monitoring for 7 days; cytopenias; infections
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Notes
- No UK marketing authorisation as of September 2026, so no NICE appraisal. Access only through a clinical trial or a company early access scheme.
- NHS England
- Not routinely funded
Sources: NICE search: afamitresgene autoleucel. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 1 Aug 2024ApprovalUS
Accelerated approval, MAGE-A4+ HLA-A*02+ advanced synovial sarcoma (SPEARHEAD-1): first TCR-T for a solid tumour source
- Aug 2025Filing / dealUS
US rights sold by Adaptimmune to US WorldMeds source
- Q2 2026Label changeUS
Label extended to patients aged 12 and older source
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Afami-cel showed that T cells can be redirected against an intracellular cancer antigen, something CAR-T cannot do, and produced meaningful responses in a rare sarcoma with few options. It opens a path to TCR-T against other shared antigens and neoantigens. Restriction to one HLA type and one antigen, plus complex manufacturing, means it will help a small, defined group.
Patients with advanced synovial sarcoma, a rare cancer of young adults with few effective drugs, now have an approved cell therapy that produces responses lasting about a year in a substantial minority, if their tissue type and tumour antigen match. It proves that engineered T cells can work against a solid tumour when a good target is present, which had been elusive. It is not a cure for most, requires specialised centres, and only a minority of patients are eligible.
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductLetetresgene autoleucel
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- PersonJean-Yves Blay
Shares SPEARHEAD-1: afamitresgene autoleucel, the first engineered T-cell receptor therapy approved for a solid tumour, in synovial sarcoma, Sarcomas (soft tissue, bone, GIST).
- PathwayAntigen presentation & immune editing
Shares MAGE-A4, HLA-A*02:01 restriction, TCR-T cell therapy.