SILVER SPRING, Md., Aug. 2, 2024 — The U.S. Food and Drug Administration (FDA) has approved Tecelra (afamitresgene autoleucel), a gene therapy for treating adults with unresectable or metastatic synovial sarcoma. This therapy is indicated for adults who have received prior chemotherapy, are HLA antigen(s) 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 authorized companion diagnostic devices.

Synovial sarcoma is a rare cancer characterized by malignant cells forming tumors in soft tissues, commonly in the extremities. This cancer can spread to other parts of the body. It affects approximately 1,000 individuals in the U.S. annually, primarily adult males in their 30s or younger. Typical treatment involves surgery to remove the tumor, sometimes supplemented with radiotherapy and/or chemotherapy for larger tumors, recurring tumors, or those that have spread.

“Potentially life-threatening cancers such as synovial sarcoma continue to have a devastating impact on individuals, especially those for whom standard treatments have limited efficacy due to tumor growth and progression,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). “The approval of this state-of-the-art immunotherapy technology provides a critical new option for a patient population in need and demonstrates the FDA’s dedication to the advancement of beneficial cancer treatments.”

Tecelra marks the first FDA-approved T cell receptor (TCR) gene therapy. It’s an autologous T cell immunotherapy using a patient’s own T cells. These T cells are modified to express a TCR that targets MAGE-A4, an antigen commonly found on synovial sarcoma cancer cells. The therapy is administered as a single intravenous dose.

Tecelra was approved under the Accelerated Approval pathway. This allows the FDA to approve drugs for serious or life-threatening conditions with unmet medical needs, based on evidence that the drug affects a surrogate endpoint reasonably likely to predict clinical benefit. While the company conducts further trials to confirm this predicted clinical benefit, a confirmatory trial is currently underway.

“Adults with metastatic synovial sarcoma, a life-threatening form of cancer, often face limited treatment options in addition to the risk of cancer spread or recurrence,” said Nicole Verdun, M.D., director of the Office of Therapeutic Products in CBER. “Today’s approval represents a significant milestone in the development of an innovative, safe and effective therapy for patients with this rare but potentially fatal disease.”

The safety and effectiveness of Tecelra were assessed in a multicenter, open-label clinical trial involving patients with inoperable and metastatic synovial sarcoma who had received prior systemic therapy and whose tumor expressed the MAGE-A4 tumor antigen. Effectiveness was measured by overall response rate and the duration of response to treatment with Tecelra. Of the 44 patients in the trial who received Tecelra, 43.2% had an overall response, and the median duration of response was six months.

Common adverse reactions associated with Tecelra included nausea, vomiting, fatigue, infections, fever, constipation, dyspnea (shortness of breath), abdominal pain, non-cardiac chest pain, decreased appetite, tachycardia (abnormally fast heart rate), back pain, hypotension, diarrhea, and edema (swelling due to fluid buildup in body tissues).

Patients treated with Tecelra may experience cytokine release syndrome (CRS), a serious immune system response that can potentially be life-threatening. CRS was observed following Tecelra administration during clinical trials. A Boxed Warning on the label provides information about this risk.

Patients might also exhibit Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS), an immune system-related syndrome occurring after certain immunotherapies, infections, secondary malignancies, or hypersensitivity reactions. They may experience severe cytopenia (abnormally low blood cell count) for several weeks after lymphodepleting chemotherapy and Tecelra infusion. Patients receiving this product should be monitored for signs of infection and advised not to drive or engage in hazardous occupations or activities for at least four weeks after receiving Tecelra.

The FDA granted Tecelra Breakthrough Therapy, Orphan Drug, and Fast Track designations for this indication.

The application was reviewed through a coordinated, cross-agency approach involving CBER, the FDA’s Oncology Center of Excellence, and the Center for Devices and Radiological Health.

The FDA granted the approval of Tecelra to Adaptimmune, LLC.

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SOURCE U.S. Food and Drug Administration