FDA Approves Tecelra Immunotherapy for Synovial Sarcoma

The U.S. Food and Drug Administration (FDA) has recently approved Tecelra, an immunotherapy for synovial sarcoma. It is a rare soft tissue cancer that is primarily found in young men’s arms and legs muscles and ligaments. 

Tecelra is a lab-engineered immune cell therapy. It has received FDA approval for solid tumor cancer and is funded by Philadelphia-based Adaptimmune. It is the first immune cell therapy that is approved by FDA. 

One of the reputed sarcoma specialists, Dr. Sandra D’Angelo said that this new treatment is a very important advancement in the development of T-cell therapies for solid tumors.  

Synovial sarcoma is diagnosed in less than 1,000 US individuals every year. It primarily affects men who are in their 30s or younger. Treatment typically involves surgery, radiation, or chemotherapy after tumor removal. 

Synovial sarcoma requires more attention and urgent treatment because it spreads to other parts of the body. It makes current therapies difficult to control once they spread. This shows there is an urgent need to develop more effective treatments. 

This new treatment involves using a person’s own immune cells that are genetically modified to detect and attack cancer cells.  

The approval of Tecelra was based on clinical trial results in 52 patients. These patients had synovial sarcoma or myxoid/round cell liposarcoma (MRCLS) and did not respond to other therapies. These patients underwent Tecelra immunotherapy.  

When researchers observed the results, they found that Tecelra showed significant results in shrinking tumors in 37% of patients after a single dose. This drug helped 39% of people with synovial sarcoma and 25% of those with MRCLS. Patients responded to the therapy for an average of 11.6 months. It indicates its potential for patients who have exhausted other treatment options. 

The FDA has approved this new treatment for metastatic synovial sarcoma. This is very important as this cancer currently has limited treatment options that are not effective for everyone. But this immunotherapy has potential to treat this cancer effectively.