FDA Takes Steps to Increase, Ease Access to CAR-T Therapies

The FDA said Friday that it was ending limitations imposed around complex blood cancer drugs, known as CAR-T therapies, by removing a safety monitoring program and easing restrictions on which health facilities can provide treatments.

The agency said it eliminated the Risk Evaluation and Mitigation Strategies, or REMS, requirements for currently approved BCMA- and CD19-directed autologous chimeric antigen receptor CAR-T cell immunotherapies.

These products are gene therapies that are currently approved to treat blood cancers, such as multiple myeloma and certain types of leukemia and lymphoma. The decision applies to Bristol Myers Squibb Co.‘s Abecma and Breyanzi; Johnson & ...