This offers hope for young adults.
The U.S. Food and Drug Administration (FDA) has approved Tecelra (afamitresgene autoleuecel) as a new treatment for synovial sarcoma, a rare soft tissue cancer that often affects young men. Tecelra, an innovative lab-engineered immune cell therapy developed by Adaptimmune, is the first of its kind to receive FDA approval for treating solid tumors. This approval is based on clinical trials that demonstrated the therapy’s potential effectiveness.
Synovial sarcoma typically develops in the muscles and ligaments of the arms and legs and is diagnosed in fewer than 1,000 people annually in the United States, primarily in men under 30. Traditional treatments have included surgery followed by radiation or chemotherapy, but these options can be less effective once the cancer has spread. Tecelra offers a new approach by modifying patients’ own immune cells to target and attack cancer cells more precisely.
Clinical trials involving 52 patients with either synovial sarcoma or another type of soft tissue sarcoma, myxoid/round cell liposarcoma (MRCLS), showed that nearly 37% of patients experienced tumor shrinkage after a single dose of Tecelra. The therapy proved beneficial for around 39% of patients with synovial sarcoma and 25% with MRCLS, with responses lasting an average of 11.6 months for those with synovial sarcoma.
Dr. Sandra D’Angelo of Memorial Sloan Kettering Cancer Center praised the approval of Tecelra, highlighting it as a significant advancement in treating solid tumors with T-cell therapies. This treatment is particularly crucial for patients who have exhausted other options and face severe challenges in managing their cancer.
Dr. Nicole Verdun from the FDA noted that this approval marks an important milestone for patients with metastatic synovial sarcoma, offering a new and effective treatment for a previously difficult-to-treat condition. Tecelra’s approval represents a promising development in the fight against this rare and potentially fatal cancer.
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