WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) recently announced it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) requirements for all currently approved BCMA- and CD19-directed autologous chimeric antigen receptor (CAR) T cell therapies. This decision reflects FDA’s confidence in the safety and management protocols for these advanced gene therapies, which are approved to treat conditions such as multiple myeloma and certain types of leukemia and lymphoma.
“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 reevaluation over time helps inform whether a REMS is still needed to ensure that the benefits of a product outweigh its risks,” stated Dr. Vinay Prasad, Chief Medical and Scientific Officer and Director of the FDA’s Center for Biologics Evaluation and Research. “Eliminating the REMS that is no longer needed also expedites the delivery of potentially curative treatments to patients and reduces burden on providers.”
Previously, REMS programs for CAR T therapies required dispensing locations, such as hospitals and clinics, to be specially certified and to maintain immediate access to tocilizumab, a medication used to treat certain treatment complications. The FDA determined that these requirements were no longer necessary because the products’ risks can be adequately managed through their existing product labeling, which includes boxed warnings for cytokine release syndrome and neurological toxicities, along with medication guides.
The products newly exempted from REMS requirements include:
- Abecma (idecabtagene vicleucel)
- Breyanzi (lisocabtagene maraleucel)
- Carvykti (ciltacabtagene autoleucel)
- Kymriah (tisagenlecleucel)
- Tecartus (brexucabtagene autoleucel)
- Yescarta (axicabtagene ciloleucel)
Dr. Richard Pazdur, Director of the FDA Oncology Center of Excellence, expressed optimism about the decision. “Physicians and institutions now have greater experience identifying and managing toxicities with the currently approved CAR T products,” he remarked. “This approach will potentially facilitate patient access to these treatments while continuing to prioritize safety.”
The FDA emphasized that these therapies remain subject to rigorous safety monitoring, including adverse event reporting and a mandatory follow-up of patients for 15 years to assess the risks of secondary malignancies and long-term safety. This monitoring is in accordance with federal regulatory requirements and underscores the agency’s commitment to safeguarding public health.
By removing the REMS obstacle, the FDA aims to streamline access to these life-saving therapies while maintaining robust oversight to ensure their safe use. The decision marks a significant step forward in expanding accessibility to cutting-edge cancer treatments.
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