US FDA Nods Tecelra To treat adults with Metastatic Synovial Sarcoma

Tecelra (afamitresgene autoleucel), a gene therapy, has been approved by the FDA for treating adults with unresectable or metastatic synovial sarcoma. Patients must have received prior chemotherapy, be positive for specific HLA antigens, and have tumours expressing the MAGE-A4 antigen.

Adaptimmune, LLC was granted approval for Tecelra by the US FDA. Synovial sarcoma is an uncommon type of cancer where cancerous cells grow and create a tumor in the body's soft tissues. This form of cancer can manifest in various areas of the body, typically appearing in the limbs. The cancer cells can also metastasize to different areas of the body.

Every year, approximately 1,000 individuals in the US are affected by synovial sarcoma, with a higher prevalence in males under the age of 30 or in their 30s. Typically, the treatment consists of surgery to eliminate the tumor and may also involve radiotherapy and/or chemotherapy if the tumor is bigger, recurs post-removal, or has spread from its initial site.

“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 tumour 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."