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# Gene Therapy for Synovia Sarcoma Approved
- URL: https://www.fdaweb.com/gene-therapy-for-synovia-sarcoma-approved/
- Published: 2024-08-02T12:00:00.000Z
- Updated: 2026-09-14T14:37:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157493

FDA has granted Adaptimmune accelerated approval for its BLA for Tecelra (afamitresgene autoleucel), a gene therapy indicated for treating adults with unresectable or metastatic synovial sarcoma 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 an agency authorized companion diagnostic device.

An [FDA release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treat-adults-metastatic-synovial-sarcoma?ref=fdaweb.com) describes synovial sarcoma as a rare form of cancer in which malignant cells develop and form a tumor in soft tissues. The cancer can occur in many parts of the body, most common are the extremities, and cancerous cells may also spread to other parts of the body, it says. Typical treatment involves surgical tumor removal and may also include radiotherapy or chemotherapy if the tumor is large, returns after being removed or has spread beyond its original location.

FDA says Tecelra is the first FDA-approved T cell receptor (TCR) gene therapy. A patient’s own T cells are “modified to express a TCR that targets MAGE-A4, an antigen (substance that normally triggers your immune system) expressed by cancer cells in synovial sarcoma.” It says, adding that it is administered as a single intravenous dose.

Approval was based on data demonstrating the overall response rate and the duration of response to treatment with Tecelra. “Among the 44 patients in the trial who received Tecelra, the overall response rate was 43.2% and the median duration of response was six months,” FDA says. Regarding safety, its says the most common adverse reactions associated with Tecelra included nausea, vomiting, fatigue, infections, fever, constipation, dyspnea, abdominal pain, non-cardiac chest pain, decreased appetite, tachycardia, back pain, hypotension, diarrhea and edema.

“Patients treated with Tecelra may experience cytokine release syndrome (CRS), which is a dangerous type of aggressive immune system response, including potentially life-threatening reactions,” the agency warns. “CRS was observed following administration of Tecelra during clinical trials. A Boxed Warning is included in the label containing information about this risk.”