Vincent Rajkumar, Professor of Medicine at the Mayo Clinic in Rochester and Editor‑in‑Chief at Blood Cancer Journal, shared a post on X:
“We have to revise how CART cell therapy is approved. Regulating it as a drug impedes progress. There are amazing innovations in CART cell therapy being developed that enhance efficacy, reduces delays, and greatly lowers cost.
With a revised regulatory approach, patients can benefit greatly. I wrote a white paper on this and we were discussing this with leaders at the FDA, before the leadership changed. Some elements of the proposal are based on this article we wrote in 2019.
Other countries are already taking the lead.”
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