AFAMITRESGENE AUTOLEUCEL
Tecelra (afamitresgene autoleucel) is a gene pharmaceutical. Afamitresgene autoleucel was first approved as Tecelra on 2024-08-01. It is used to treat synovial sarcoma in the USA.
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Trade Name
FDA
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Tecelra
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Afamitresgene autoleucel
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| tecelra | afamitresgene autoleucel | US WorldMeds | N-125789 RX | 2024-08-01 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| tecelra | Biologic Licensing Application | 2026-01-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| synovial sarcoma | — | D013584 | — |
Agency Specific
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Clinical
Clinical Trials
4 clinical trials
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Synovial sarcoma | D013584 | — | — | 2 | 2 | — | — | 1 | 4 |
| Myxoid liposarcoma | D018208 | — | — | 1 | 1 | — | — | 1 | 3 |
| Sarcoma | D012509 | — | — | 1 | 1 | — | — | — | 2 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 1 | 1 | — | — | — | 1 |
| Osteosarcoma | D012516 | — | — | 1 | 1 | — | — | — | 1 |
| Neurofibrosarcoma | D018319 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | — | — | — | — | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | — | — | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | 1 | — | — | — | — | 1 |
| Esophageal neoplasms | D004938 | — | C15 | 1 | — | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | — | — | — | — | 1 |
| Melanoma | D008545 | — | — | 1 | — | — | — | — | 1 |
| Liposarcoma | D008080 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | AFAMITRESGENE AUTOLEUCEL |
| INN | afamitresgene autoleucel |
| Description | Afamitresgene autoleucel, sold under the brand name Tecelra is a T cell immunotherapy used for the treatment of synovial sarcoma. It is a T cell receptor (TCR) gene therapy. It is administered as a single intravenous dose.
|
| Classification | Gene |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL4802254 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | CUY18BJ7BP (ChemIDplus, GSRS) |
Target
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Safety
Black-box Warning
Black-box warning for: Tecelra
Adverse Events
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