Tecelra Approved for Synovial Sarcoma

Adaptimmune Therapeutics received accelerated approval from the U.S. Food and Drug Administration (FDA) for Tecelra^® (afamitresgene autoleucel) on Aug. 1, 2024. It is a T cell receptor (TCR) gene therapy 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 melanoma-associated antigen A4 (MAGE-A4 antigen) as determined by FDA-approved or cleared companion diagnostic devices. Tecelra will be given as a one-time intravenous (IV) infusion of a patient’s own T cells that have been genetically modified to target MAGE-A4. The recommended dose is between 2.68 x 10⁹ to 10 x 10⁹ MAGE-A4 TCR-positive T cells. Adaptimmune expects patients to begin receiving treatment in the fourth quarter of this year. The list price for Tecelra is $727,000 for the one-time infusion. Full prescribing information can be found here.

At a Glance

• Brand Drug: Tecelra^® (afamitresgene autoleucel)
• Manufacturer: Adaptimmune Therapeutics
• Date Approved: Aug. 1, 2024
• Indication: 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
• Dosage Forms Available: cell suspension containing 2.68 x 10⁹ to 10 x 10⁹ MAGE-A4 TCR positive T cells for IV infusion
• Launch Date: Q4:2024
• Estimated Annual Cost: $727,000
• Synovial sarcoma is a type of cancer that develops in the soft tissues of the body, primarily around the joints of the hip, knee, ankle, elbow, wrist, and shoulder. It is commonly diagnosed in males 30 years of age and younger. The five-year survival rate for patients with metastatic disease is approximately 20%.
• Approximately 1,000 people are diagnosed with synovial sarcoma each year in the U.S. About half of these patients may be candidates for treatment with Tecelra.
• Approval of Tecelra was based on a clinical trial that demonstrated a 43% overall response rate and six-month median duration of response.
• Common adverse reactions may include cytokine release syndrome (CRS), nausea, vomiting, fatigue, infections, fever, constipation, difficulty breathing, abdominal pain, non-cardiac chest pain, decreased appetite, elevated heart rate, back pain, low blood pressure, diarrhea, swelling, low white blood cells, low red blood cells, and low platelets.
• The labeling for Tecelra contains a boxed warning concerning the risk for CRS, a potentially life-threatening immune system response to therapy.
• Adaptimmune received accelerated approval for Tecelra; therefore, additional studies that demonstrate a clinical benefit are required before FDA will consider granting full approval. A confirmatory trial is currently ongoing.
• Tecelra was approved under the FDA’s Priority Review process. It has Orphan Drug and Regenerative Medicine Advanced Therapy status.