FDA Grants ADP-A2M4 RMAT Designation for Synovial Sarcoma

December 23, 2019 – The FDA has granted a Regenerative Medicine Advanced Therapy (RMAT) designation to ADP-A2M4 (MAGE-A4) as a treatment for patients with synovial sarcoma. The RMAT designation was based on updated data from a phase I trial that was presented at the 2019 CTOS Annual Meeting, in which 50% of patients achieved clinical responses with ADP-A2M4. The agent is a genetically engineered autologous-specific peptide-enhanced … (leggi tutto)