Afamitresgene autoleucel

TECELRA is indicated for the treatment of adults and pediatric patients 12 years of age and older 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. TECELRA is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults and pediatric patients 12 years of age and older 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.

TECELRA is a genetically modified autologous T cell immunotherapy consisting of CD4 and CD8 positive T cells transduced with a self-inactivating LV to express an affinity-enhanced TCR specific for human MAGE-A4 on the cell surface. The TCR recognizes an HLA-A*02 restricted MAGE-A4 peptide. MAGE-A4 is an intracellular cancer-testis antigen that has restricted expression in normal tissues and is expressed in synovial sarcoma. Antigen-specific activation of TECELRA via TCR-peptide-HLA-A*02 complex results in T cell proliferation, cytokine secretion, and killing of MAGE-A4/HLA-A*02 expressing synovial sarcoma cells.

For autologous use only. For intravenous use only. Prior to infusion Verify patient's identity prior to infusion. Administer a lymphodepleting regimen of cyclophosphamide and fludarabine. Premedicate with acetaminophen and an H1-antihistamine. TECELRA Dose and Administration The recommended dose is between 1.62 × 10 9 to 10 × 10 9 MAGE-A4 T cell receptor (TCR) positive T cells. Administer each infusion bag within one hour of thawing. DO NOT USE a leukodepleting filter. DO NOT USE prophylactic systemic corticosteroids.

DO NOT use TECELRA in patients who are heterozygous or homozygous for HLA-A*02:05P.

Boxed warning (cytokine release syndrome): Cytokine Release Syndrome (CRS), which may be severe or life-threatening, occurred in patients receiving TECELRA. At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care. Ensure that healthcare providers administering TECELRA have immediate access to medications and resuscitative equipment to manage CRS. Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Monitor for ICANS events for at least 2 weeks after treatment with TECELRA. Effects on Ability to Drive and Use Machines: Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 2 weeks after receiving TECELRA.

Most common adverse reactions (≥ 20%) were, cytokine release syndrome, nausea, fatigue, musculoskeletal pain, infections, pyrexia, constipation, vomiting, headache, diarrhea, cough, tachycardia, edema, dyspnea, and rash. Grade 3 or 4 laboratory abnormalities (≥20%) were lymphocyte count decreased, white blood cell count decreased, neutrophil count decreased and red blood cell count decreased. The most common serious adverse reactions (≥ 5%) were cytokine release syndrome and infections.

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Store TECELRA in the original packaging, containing the cassette(s) protecting the infusion bag(s), in the vapor phase of liquid nitrogen at less than or equal to -130°C.