Words by Isabel O’Brien
The FDA has announced the elimination of Risk Evaluation and Mitigation Strategies (REMS) for all currently approved BCMA- and CD19-directed CAR T-cell immunotherapies.
A REMS is a safety programme that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. BCMA- and CD19 are used for the treatment of several blood cancers, including multiple myeloma and certain types of leukaemia and lymphoma.
The US regulator stated that it believes the safety and effectiveness of these immunotherapies can be assured without a REMS, following a period of clinical experience and monitoring. The agency noted that the removal of REMS will reduce administrative burdens for providers and potentially expedite patient access to these treatments.
“The FDA has taken the bold step to remove the Risk Evaluation and Mitigation Strategy requirement from giving CAR T therapies. REMS is a useful safety system, but re-evaluation over time helps inform whether a REMS is still needed to ensure that the benefits of a product outweigh its risks,” said Dr Vinay Prasad, Chief Medical and Scientific Officer and Director, Center for Biologics Evaluation and Research, FDA.
Dr Richard Pazdur, Oncology Center of Excellence Director, FDA, added: “Physicians and institutions now have greater experience identifying and managing toxicities with the currently approved CAR T products. This approach will potentially facilitate patient access to these treatments while continuing to prioritise safety.”
The FDA confirmed that safety monitoring will continue through adverse event reporting and mandatory post-marketing observational studies, including long-term follow-up for up to 15 years after product administration. The agency added that it remains committed to ongoing oversight and will inform the public of any new safety information as it arises.
