The Center for Biologics Evaluation and Research’s 5 February 2021 approval of Bristol Myers Squibb Company’s chimeric antigen receptor T-cell (CAR-T) therapy Breyanzi is notable not only for its designations – in addition to the RMAT, Breyanzi holds a breakthrough therapy designation – but as the first major product to have been approved after a COVID-19-induced missed user fee goal.
When Breyanzi’s 16 November 2020 user fee goal passed without a letter from the US FDA, Mallinckrodt plc’s bioengineered skin tissue StrataGraft looked like it could become the first RMAT-designated agent approved by the FDA