FDA Lifts REMS Requirement for CAR-T Cell Cancer Therapies

The U.S. Food and Drug Administration (FDA) has removed the Risk Evaluation and Mitigation Strategies (REMS) requirement for all currently approved CAR-T cell therapies, a move expected to improve patient access to these advanced cancer treatments.

CAR-T cell therapy, a form of gene therapy used to treat blood cancers such as leukemia, lymphoma, and multiple myeloma, involves reprogramming a patient’s T-cells to attack cancer cells. Despite serious side effects, including cytokine release syndrome and neurological toxicities, the FDA concluded that existing labeling and boxed warnings are sufficient to communicate these risks without the need for REMS.

This regulatory update affects therapies including Bristol-Myers Squibb’s Breyanzi and Abecma (developed with 2seventy bio), Johnson & Johnson’s Carvykti (with Legend Biotech), Novartis’ Kymriah, and Gilead’s Tecartus and Yescarta. Gilead confirmed label updates to reflect the FDA’s decision, stating it would ease the burden on healthcare providers and expand access to potentially curative treatments.

Bristol-Myers Squibb echoed this sentiment, emphasizing its commitment to breaking down barriers to CAR-T access. These therapies have been a breakthrough in oncology, offering new hope for patients with few alternatives.

In January 2024, the FDA had mandated additional safety warnings for CAR-T drugs following reports of secondary T-cell malignancies, including leukemia and lymphoma. Despite these risks, the agency now believes they can be effectively managed through existing safety measures.

With this change, the FDA aims to streamline access to CAR-T therapies while maintaining patient safety, reinforcing its support for innovation in personalized cancer treatment. This decision marks a significant regulatory shift that could accelerate the adoption of CAR-T across oncology care.