Adaptimmune Therapeutics announces completion of the next step in bringing its new immunotherapy for advanced synovial sarcoma to patients.
Adaptimmune Therapeutics announced completion of the next step in bringing its new immunotherapy for advanced synovial sarcoma to patients. By completing its submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for afami-cel, the treatment is now eligible for a Priority Review, which would shorten the FDA’s review to 8 months instead of the standard 12 months. Submission of the BLA is supported by positive data from the SPEARHEAD-1 clinical trial, which met its primary endpoint for efficacy. Data from the trial were recently presented at the Connective Tissue Oncology Society (CTOS) 2023 Annual Meeting.