Tecelra FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 5, 2024.

FDA Approved: Yes (First approved August 1, 2024)
Brand name: Tecelra
Generic name: afamitresgene autoleucel
Dosage form: Suspension for Intravenous Infusion
Company: Adaptimmune Therapeutics plc
Treatment for: Synovial Sarcoma

Tecelra (afamitresgene autoleucel) is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy used for the treatment of adults with unresectable or metastatic synovial sarcoma.

• Tecelra is 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.
  This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
• Synovial sarcoma is a type of soft tissue sarcoma that occurs primarily in the soft tissue of the extremities. Most cases of synovial sarcoma are thought to be associated with a gene mutation that results when parts of chromosome 18 and chromosome X join abnormally.
• Tecelra is an immunotherapy made with a patient’s own T cells. It contains MAGE-A4 T cell receptor (TCR) positive T cells that work to recognize and attack synovial sarcoma cells that express MAGE-A4.
• FDA accelerated approval of Tecelra was based on results of the SPEARHEAD-1 (Cohort 1) trial of 44 patients which demonstrated an overall response rate of 43.2% with a complete response rate of 4.5%. The median duration of response was 6 months (95% CI: 4.6, not reached). Among patients who were responsive to the treatment, 39% had a duration of response of 12 months or longer.
• Tecelra is administered as a single dose by intravenous infusion. Patients will receive a lymphodepleting regimen of cyclophosphamide and fludarabine, and premedication with acetaminophen and an H1-antihistamine prior to receiving the infusion of Tecelra.
• The Tecelra product label carries a Boxed Warning for cytokine release syndrome (CRS), which may be severe or life-threatening. Warnings and precautions associated with Tecelra include Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), severe cytopenia, risk of infections, secondary malignancies,  hypersensitivity reactions, and the potential for neurologic events in the four weeks following the infusion.
• 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. Grade 3 or 4 laboratory abnormalities include decreased lymphocyte count, decreased neutrophil count, decreased white cell blood count, decreased red blood cell count, and decreased platelet count.
  Common serious adverse reactions include cytokine release syndrome and pleural effusion.

Development timeline for Tecelra

Further information

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