The U.S. Food and Drug Administration (FDA) has granted accelerated approval for the immunotherapy afamitresgene autoleuecel (Tecelra®, also known as afami-cel) for the treatment of adults with a rare soft tissue cancer called synovial sarcoma.
Memorial Sloan Kettering Cancer CenterAug 2 2024 The U.S. Food and Drug Administration has granted accelerated approval for the immunotherapy afamitresgene autoleuecel for the treatment of adults with a rare soft tissue cancer called synovial sarcoma .The clinical trial that resulted in the drug's approval was led by Memorial Sloan Kettering Cancer Center sarcoma specialist and immunotherapy expert Sandra D'Angelo, MD.
"Sarcoma in general, and synovial sarcoma in particular, is a type of cancer where more treatments are desperately needed," Dr. D'Angelo explains. "Once the disease spreads to other parts of the body, it is very difficult to control with the therapies we have now." Related StoriesAfami-cel is not a CAR T therapy but is in a related category called T cell receptor therapy. The T cells are engineered to carry an extra tool that allows them to recognize proteins, or markers, that are hiding inside cancer cells. By contrast, CAR T therapies can only see these cancer markers when they are on the outside of tumor cells.
Results of trial for rare soft tissue sarcomas The phase 2 clinical trial that resulted in the drug's approval was published in The Lancet in April 2024. Dr. D'Angelo was lead author of the paper, which reported that afami-cel significantly shrank sarcoma tumors in more than one-third of patients. "These findings are significant for a group of patients who have largely exhausted other treatment options," Dr. D'Angelo says.
Sarcoma Antigen Blood Cancer Chimeric Antigen Receptor Clinical Trial Food Immunotherapy Protein Receptor Syndrome Synovial Sarcoma Tumor
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