Dec. 03, 2019: U.S. Food and Drug Administration (FDA) approved Adaptimmune Therapeutic’s Regenerative Medicine Advanced Therapy (RMAT) designation for ADP-A2M4 for the treatment of synovial sarcoma.
If product have regenerative medicine therapy, such as a T-cell therapy, and is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition then that is eligible for RMAT designation.
Data from patients with synovial sarcoma treated in the expansion phase of Adaptimmune’s Phase 1 trial with ADP-A2M4 were recently presented at CTOS. There was an overall response rate of 50%, and a disease control rate of 93%. https://ir.adaptimmune.com/news-releases/news-release-details/regenerative-medicine-advanced-therapy-designation-granted-fda