BMS’ Breyanzi Beats COVID-19 Constraints, Emerges As First RMAT Approval

 
• By Bridget Silverman
  
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After missing user fee date due to inspection delay, US FDA clears the CAR-T therapy for treatment of adults with relapsed or refractory large B-cell lymphoma.

BMS is giving itself a high five after the Breyanzi approval.

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...

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