First Engineered T Cell Therapy for Solid Tumors Approved by the FDA

Inside Precision Medicine August 5, 2024
IPM Staff

The immunotherapy afamitresgene autoleucel (afami-cel) for the treatment of adults with the rare soft tissue cancer called synovial sarcoma was granted accelerated approval late last week by the U.S. Food and Drug Administration (FDA). Afami-cel is the first engineered T cell therapy to receive FDA approval for treatment of a solid tumor.

“This treatment offers an important new option for people with this rare cancer,” said Sandra D’Angelo, MD, a sarcoma specialist who led the clinical at Memorial Sloan Kettering Cancer Center (MSK). “It is also an important step forward in the development of T cell therapies for solid tumors, which has been a major challenge.”

Chimeric antigen receptor (CAR) T cell therapies have been effectively treating various forms of...

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