BioPharma Dive August 2, 2024
Adaptimmune’s Tecelra is the first TCR cell therapy to reach the U.S. market, but arrives with only modest sales expectations.
The Food and Drug Administration on Thursday approved a new type of cellular medicine, clearing a therapy developed by the biotechnology company Adaptimmune for a rare soft tissue cancer called synovial sarcoma.
The agency granted Adaptimmune’s therapy, formerly known as afami-cel and to be sold as Tecelra, an accelerated approval for use in some people with metastatic synovial sarcoma who previously received chemotherapy. Those people must have certain immune signatures and tumors expressing a protein, MAGE-A4, that Tecelra is designed to target.
The FDA based its decision on Tecelra’s ability to spur tumor responses in about 43% of people who...
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