FDA Drops REMS Programs for Some CAR-Ts
Specifically, the FDA removed the Risk Evaluation and Mitigation Strategy (REMS) program requirements from two BCMA-directed CAR T-cell therapies for multiple myeloma — ciltacabtagene autoleucel (Carvykti; Janssen) and idecabtagene vicleucel (Abecma; BMS) — and one CD19-directed therapy for lymphoma, lisocabtagene maraleucel (Breyanzi; BMS).
In a June 26 letter to Janssen explaining the move, the agency said that 'the established management guidelines and extensive experience of the medical hematology/oncology community in diagnosing and managing the risks of cytokine release syndrome (CRS) and neurologic toxicities across products in the class of BCMA- and CD19-directed autologous CAR T cell immunotherapies' means that REMS programs are no long necessary to ensure safe use.
The agency further streamlined the labels of the two BMS therapies by reducing requirements to stay near a health facility after treatment from 4 to 2 weeks and by dropping driving restrictions after treatment from 8 to 2 weeks.
In a press statement, BMS applauded the 'class-wide label updates that will help ease known barriers to treatment and administration while maintaining patient safety.'
The company also noted that recent studies have made it clear that the 'vast majority of serious adverse events' with CAR T-cell therapy occur within the first 2 weeks of infusion.
'Today's announcement reduces some of the most onerous requirements that may have previously discouraged patients, particularly those who live far from a treatment center, from seeking the potentially transformational effects of cell therapy,' said Sally Werner, RN, BSN, CEO of Cancer Support Community, in the press release.
M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com
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