BioCentury
ARTICLE | Regulation

FDA panel backs BCMA CAR Ts, and puts rapid manufacturing back in spotlight

FDA’s advisers support Carvykti and Abecma, but call for better management of patients awaiting CAR T treatment

March 16, 2024 1:46 AM UTC

Both BCMA-directed CAR T cell therapies up for discussion during an FDA advisory committee meeting on Friday earned committee support in earlier lines of treatment for multiple myeloma, but the biggest takeaway from the discussion was the need to optimize bridging therapies to prevent deaths while patients wait for the CAR T cells to be produced.

Better protocols for bridging therapy could offer short-term management of the problem, but in the long term, strategies are needed to get CAR T cell therapies to patients faster. Rapid manufacturing will be part of the solution...