Afamitresgene autoleucel (Tecelra)

Mechanism of action

From the NCI Drug Dictionary: A preparation of autologous human T-lymphocytes transduced with a lentiviral vector encoding an affinity-enhanced T-cell receptor (TCR) specific for the human leukocyte antigen (HLA)-A2-restricted peptide human melanoma antigen A4 (MAGE-A4) C1032, with potential immunostimulatory and antineoplastic activities. Upon leukapheresis, isolation, transduction, expansion ex vivo, and reintroduction into the patient, afamitresgene autoleucel targets and binds to tumor cells expressing MAGE-A4. This results in cell death of MAGE-A4-expressing tumor cells.

Diseases for which it is used

• Liposarcoma
• Synovial sarcoma

History of changes in FDA indication

• 2024-08-02: Granted accelerated approval for 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. (Based on SPEARHEAD-1)

Also known as

• Code name: ADP-A2M4
• Generic name: afami-cel
• Brand name: Tecelra