The US FDA has approved afamitresgene autoleucel for the treatment of advanced synovial sarcoma, a rare form of cancer affecting about 1000 people in the US each year. This therapy, the first engineered cell therapy for a solid tumor, is a promising strategy for targeting solid tumors by modifying existing receptors to recognize an array of antigens on the surface of cancer cells. The approval was based on a trial showing an overall response rate of 43.2% and a median duration of response of 6 months. The therapy has a boxed warning for cytokine release syndrome and common adverse reactions include nausea, fatigue, and infections.
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FDA Approves First Engineered Cell Therapy for a Solid Tumor
