Adaptimmune’s TECELRA Becomes First FDA-Approved Engineered Cell Therapy for Solid Tumors
Adaptimmune Therapeutics announced that the FDA has approved (afamitresgene autoleucel), which will be marketed under the brand name TECELRA, for the treatment of unresectable or metastatic synovial sarcoma. This marks the first engineered cell therapy for solid tumors in the U.S. and the first new therapy for synovial sarcoma in over a decade. The approval is based on the overall response rate and duration of response from the SPEARHEAD-1 trial, which showed a 43% response rate.
Adrian Rawcliffe, Adaptimmune's Chief Executive Officer, stated, “The approval of TECELRA is a...
