FDA Eliminates REMS for Approved CAR T-Cell Therapies

The Food and Drug Administration recently eliminated the risk evaluation and mitigation strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T-cell therapies.

FDA determined that a REMS is no longer necessary to ensure the benefits of these therapies outweigh their risks, citing the hematology/oncology community’s established experience and guidelines for managing cytokine release syndrome and neurologic toxicities. The agency also aims to reduce the burden on the health care system associated with REMS compliance and help improve access to these products.

Affected Therapies

FDA ended REMS programs for the following therapies:

• Axicabtagene ciloleucel (Yescarta, Kite Pharma).
• Brexucabtagene autoleucel (Tecartus, Kite Pharma).
• Ciltacabtagene autoleucel (Carvykti, Janssen Biotech/Legend Biotech).
• Idecabtagene vicleucel (Abecma, Bristol Myers Squibb/2seventy bio).
• Lisocabtagene maraleucel (Breyanzi, Bristol Myers Squibb).
• Tisagenlecleucel (Kymriah, Novartis).

Following elimination of the REMS, hospitals and their associated clinics dispensing these therapies are no longer required to be specially certified or to maintain on-site, immediate access to tocilizumab. Additionally, FDA approved updates to the product labeling to reflect revised patient monitoring guidance.

The agency emphasized that elimination of the REMS does not change existing FDA requirements for manufacturers to conduct postmarketing observational safety studies. These studies include monitoring for secondary malignancies and long-term safety, with follow-up of patients for 15 years after product administration.