By Fineline Cube 
The U.S. Food and Drug Administration (FDA) last week announced the removal of Risk Evaluation and Mitigation Strategies (REMS) requirements for approved BCMA- and CD19-targeted CAR-T cell therapies. This decision simplifies the distribution and administration processes for these therapies.
Impacted Therapies
The FDA’s decision affects several marketed CAR-T therapies, including Bristol-Myers Squibb’s Abecma and Breyanzi, Gilead Sciences’ Yescarta and Tecartus, Johnson & Johnson/Legend Bio’s Carvykti, and Novartis’ Kymriah. Autolus’ CD19 CAR-T therapy Aucatzyl, approved in November 2024, was not subject to REMS from the start.
Regulatory Impact
The REMS removal eliminates the need for special certification of hospitals/clinics for product distribution and the mandatory on-site availability of tocilizumab for immediate use. The FDA now deems existing product labeling sufficient to communicate safety information, including boxed warnings for cytokine release syndrome (CRS) and neurologic toxicities, as well as medication guides.-Fineline Info & Tech