FDA Eases Access To Life-Saving Gene Therapies For Blood Cancers

The U.S. Food and Drug Administration (FDA) announced on Friday that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR T cell immunotherapies. 

These products are gene therapies currently approved to treat blood cancers, 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,” said FDA Vinay Prasad, Chief Medical and Scientific Officer and Director, Center for Biologics Evaluation and Research. 

Also Read: FDA Eases Rules For Bristol Myers’ Cell Therapies For Blood Cancers

“Eliminating the REMS that is no longer needed also expedites the delivery of potentially curative treatments to patients and reduces the burden on providers,” he added.

A REMS is a safety program that the FDA ...