An RMAT is a “Regenerative Medicine Advanced Therapy” designation and this is a list of the 39 publicly announced RMAT Designations to date. At least 5 more have bee approved, as the FDA states it has received 115 requests and issued 44. This means 38% of RMAT requests get approved.
Sponsors of cell and gene therapies are eligible to obtain an RMAT designation from the U.S. FDA if their product is intended to treat serious or life-threatening diseases and there is preliminary clinical evidence that it can address unmet medical needs.
Recent additions include Adaptimmune Therapeutics T-cell therapy ADP-A2M4 for the treatment of Synovial Sarcoma n December 3, 2019, as well as Bristol-Myers Squibb’s Liso-cel, an autologous anti-CD19 CAR-T cell therapy.
