CAR-T Changes Should Boost Uptake, but Challenges Still Remain

Jul 17
Jul 17, 2025

Less than a year after the FDA approved the first chimeric antigen receptor-T cell therapy without a Risk Evaluation Mitigation Strategy program, the agency has eliminated the REMS for the other six CAR-Ts. At the same time, the FDA loosened other restrictions on patients, moves that should increase uptake of the agents, say industry experts.

“A REMS is no longer necessary to ensure that the benefits of these CAR T cell immunotherapies outweigh their risks and to minimize the burden on the healthcare delivery system of complying with the REMS,” said the FDA on June 26. The programs initially were in place because of the risks of cytokine release syndrome (CRS) and neurologic toxicities, including immune effector cell-associated neurotoxicity syndrome (ICANS), potentially fatal reactions.
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Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.