Afamitresgene autoleucel
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 gene therapy. It is administered as a single intravenous dose.
The most common adverse reactions include cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, abdominal pain, non-cardiac chest pain, decreased appetite, tachycardia, back pain, hypotension, diarrhea, and edema.
Afamitresgene autoleucel was approved for medical use in the United States in August 2024. Afamitresgene autoleucel is the first T cell receptor gene therapy approved by the US Food and Drug Administration.
Medical uses
Afamitresgene autoleucel is a melanoma-associated antigen A4 -directed genetically modified autologous T cell immunotherapy indicated for the 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.Afamitresgene autoleucel is an autologous T cell immunotherapy composed of a recipient's own T cells. T cells in afamitresgene autoleucel are modified to express a T cell receptor that targets MAGE-A4, an antigen expressed by cancer cells in synovial sarcoma.
Adverse effects
The US Food and Drug Administration prescribing information includes a boxed warning for serious or fatal cytokine release syndrome, which may be severe or life-threatening.The most common adverse reactions include cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, abdominal pain, non-cardiac chest pain, decreased appetite, tachycardia, back pain, hypotension, diarrhea, and edema. The most common grade 3 or 4 laboratory abnormalities include lymphocyte count decreased, neutrophil count decreased, white cell blood count decreased, red blood cell decreased, and platelet count decreased.
Recipients may also exhibit immune effector cell-associated neurotoxicity syndrome, an immune system-related syndrome that can occur following some immunotherapies, infections, secondary malignancies, or hypersensitivity reactions, and severe cytopenia for several weeks following lymphodepleting chemotherapy and infusion of afamitresgene autoleucel.