FDA removes access barriers to CAR-T therapy

The Food and Drug Administration is taking steps to ease limitations imposed around currently approved complex cancer immunotherapies known as chimeric antigen receptor (CAR)-T therapies.

The agency announced that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for CAR-T cell therapies that treat blood cancers, such as multiple myeloma and certain types of leukemia and lymphoma. The FDA can require REMS programs for certain medications with strong safety concerns to help ensure the medication’s benefits outweigh its risks. 

“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,” the news release said.

Read More: FDA

The article presented here is intended to inform you about the broader media perspective on dentistry, regardless of its alignment with the ADA's stance. It is important to note that publication of an article does not imply the ADA's endorsement, agreement, or promotion of its content.