The U.S. Food and Drug Administration (FDA) has approved Tecelra (afamitresgene autoleucel) for the treatment of adults with unresectable or metastatic synovial sarcoma who have previously received chemotherapy. This approval is specifically for patients who are positive for certain HLA antigens (A02:01P, -A02:02P, -A02:03P, or -A02:06P) and whose tumors express the MAGE-A4 antigen, as determined by FDA-approved diagnostic tests.

Synovial sarcoma is a rare cancer that typically forms in the soft tissues of the body, most often in the extremities, and can spread to other areas. It affects about 1,000 people each year in the U.S., mostly adult males in their 30s or younger. Treatment usually involves surgery, and may also include radiation and chemotherapy if the tumor is large, recurrent, or metastasized.

Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research (CBER), stated, "Synovial sarcoma is a severe cancer, particularly when conventional treatments are inadequate. The approval of Tecelra represents a major advancement in immunotherapy for this patient population, reflecting the FDA's commitment to supporting effective cancer treatments."

Tecelra is the first T cell receptor (TCR) gene therapy approved by the FDA. It is an autologous T cell therapy, meaning it uses a patient’s own T cells, which are genetically engineered to target the MAGE-A4 antigen found on cancer cells in synovial sarcoma. The therapy is administered as a single intravenous dose.

Tecelra received approval through the Accelerated Approval pathway, which allows for earlier approval of drugs for serious conditions where there is an unmet medical need and the drug shows potential benefit on a surrogate endpoint. A follow-up trial is ongoing to further confirm Tecelra’s clinical benefit.

Nicole Verdun, M.D., director of the Office of Therapeutic Products in CBER, commented, "Patients with metastatic synovial sarcoma often have limited treatment options and face a high risk of cancer recurrence. Today's approval is a significant milestone for providing a new, innovative treatment option for this rare and life-threatening disease."

The safety and effectiveness of Tecelra were evaluated in a multicenter, open-label trial involving patients with inoperable and metastatic synovial sarcoma who had received prior systemic therapy and whose tumors expressed the MAGE-A4 antigen. The trial showed an overall response rate of 43.2% and a median duration of response of six months.

Common side effects include nausea, vomiting, fatigue, infections, fever, constipation, shortness of breath, abdominal pain, chest pain, decreased appetite, rapid heart rate, back pain, low blood pressure, diarrhea, and swelling. Patients may also experience cytokine release syndrome (CRS) and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS). Severe cytopenia may also occur after treatment. Patients should be monitored for signs of infection and are advised to avoid driving or engaging in hazardous activities for at least four weeks post-treatment.

Tecelra was granted Orphan Drug, Regenerative Medicine Advanced Therapy, and Priority Review designations. The application was reviewed through a collaborative effort involving CBER, the FDA's Oncology Center of Excellence, and the Center for Devices and Radiological Health.

 

Source: prnewswire.com

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