FDA Drops REMS for CAR-T Rx; Will Access Expand? - Prime Therapeutics
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FDA Drops REMS for CAR-T Rx; Will Access Expand?
As of June 26, 2025, the FDA has removed certain Risk Evaluation and Mitigation Strategy (REMS) requirements from all but one of the currently approved B-cell maturation antigen (BCMA)- and CD19-directed autologous chimeric antigen receptor T-cell (CAR-T) immunotherapies.

About Prime Therapeutics

Prime Therapeutics LLC (Prime) is a diversified pharmacy solutions organization. We offer innovative pharmacy benefit management, specialty and medical drug management, and state government solutions to millions of people across the country. At Prime, we’re reimagining pharmacy solutions to provide the care we’d want for our loved ones. We challenge the way it’s always been done to develop intelligently designed solutions that deliver savings, simplicity and support to help people achieve better health. For more information, visit us at PrimeTherapeutics.com or follow us on LinkedIn.