Adaptimmune Therapeutics has revealed that the U.S. FDA accepted its Biologics License Application (BLA) for afami-cel, an investigational engineered T-cell therapy designed for advanced synovial sarcoma.
The application is now under priority review, with a targeted action date set for August 4, 2024, according to the Prescription Drug User Fee Act (PDUFA).
Adrian Rawcliffe, Adaptimmune’s CEO, expressed optimism with the FDA’s acceptance of the BLA submission, bringing them closer to reshaping synovial sarcoma treatment.
Rawcliffe emphasized the significant potential within their franchise, highlighting the prospect of launching afami-cel as the first engineered T-cell therapy for solid tumor cancer upon approval, supported by the necessary capabilities and capital.
The FDA’s acceptance is backed by favorable results from Cohort 1 of the pivotal SPEARHEAD-1Sarcoma trial, meeting its primary efficacy endpoint. These trial findings were presented at the 2023 Annual Meeting of the Connective Tissue Oncology Society (CTOS).
Source: Adaptimmune Announces U.S. FDA Acceptance of Biologics License Application for Afami-cel for the Treatment of Advanced Synovial Sarcoma with Priority Review
https://www.adaptimmune.com/investors-and-media/news-center/press-releases/detail/260/adaptimmune-announces-u-s-fda-acceptance-of-biologics
