The FDA has eliminated Risk Evaluation and Mitigation Strategies for all currently approved BCMA- and CD19-directed autologous CAR-T cell immunotherapies, determining that the safety program is no longer necessary to ensure the benefits of the therapies outweigh the risks.
The FDA said existing clinical experience and improved understanding of managing severe side effects, such as cytokine release syndrome and neurologic toxicities, mean the products can be safely administered without the REMS requirements, according to a June 26 news release from the agency.
The decision applies to six CAR-T cell therapies: Abecma, Breyanzi, Carvykti, Kymriah, Tecartus and Yescarta. Until now, the therapies were dispensed only by specifically certified hospitals and clinics with immediate access to tocilizumab, an immunosuppressive drug used to treat CRS.
Product labeling for each therapy has been updated to reflect the removal of REMS and reinforce safe use practices. New guidance also includes monitoring patients for at least two weeks post-administration.
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