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Adaptimmune Therapeutics Seeking FDA Approval for Synovial Sarcoma T-Cell Therapy

NEW YORK – Adaptimmune Therapeutics said this week that it has filed for US Food and Drug Administration approval of its MAGE-A4-directed engineered T-cell therapy afamitresgene autoleucel (afami-cel) as treatment for patients with synovial sarcoma.

The FDA accepted Adaptimmune's afami-cel biologics license application and granted it priority review. The application includes data from cohort 1 of Adaptimmune's pivotal SPEARHEAD-1 clinical trial, in which 39 percent of advanced, MAGE-A4-positive synovial sarcoma patients responded to afami-cel and the median duration of response was 12 months. The median overall survival was 17 months, and two years after treatment, 70 percent of patients treated with afami-cel were still alive.

The FDA is expected to decide whether to approve afami-cel by Aug. 4. If the FDA approves the autologous cell therapy, it will be the first commercially available engineered T-cell therapy for solid tumors. According to Adaptimmune, if afami-cel reaches the market, it will be the first effective treatment option for this patient population in more than a decade.

Last year, Adaptimmune, headquartered in Oxford, UK, merged with Cambridge, Massachusetts-based TCR2 and began focusing on developing cell therapies for solid tumors, including engineered T-cell therapies.