Removal of REMS Requirements Improves Access to CAR T-Cell Therapy Across Hematologic Malignancies

The FDA’s decision to eliminate the Risk Evaluation and Mitigation Strategies (REMS) requirements for all currently approved CD19- and BCMA-directed autologous CAR T-cell immunotherapies in hematologic malignancies reflects growing confidence within the oncology community for identifying and managing associated toxicities.¹ The decision is expected to expand access to these therapies by reducing longstanding socioeconomic, geographic, and logistical barriers, according to expert hematologists interviewed by OncLive®