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# Adaptimmune BLA for Synovial Sarcoma Accepted
- URL: https://www.fdaweb.com/adaptimmune-bla-for-synovial-sarcoma-accepted/
- Published: 2024-02-01T12:00:00.000Z
- Updated: 2026-09-14T14:21:55.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156272

FDA has accepted for priority review an Adaptimmune Therapeutics BLA for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarcoma. The agency has assigned an 8/4 user fee review action target date.

The submission is based on data from cohort 1 of the company’s pivotal trial SPEARHEAD-1, which Adaptimmune says met its primary endpoint for efficacy. The company had earlier reported that about 39% of patients who received afami-cel in trial had clinical responses with a median duration of response of about 12 months. Additionally, it said median overall survival was 17 months compared to less than 12 months historically for those with synovial sarcoma who received two or more prior lines of therapy.

Afami-cel is described as an engineered T-cell receptor T-cell therapy, targeted to the MAGE A4 cancer target as a single-dosed treatment.