REMS Programs for BCMA-Directed Therapies: Background, Best Practices, and Institutional Protocols

In 'REMS Programs for BCMA-Directed Therapies: Background, Best Practices, and Institutional Protocols,' the expert oncologists and oncology pharmacists explored the following questions:

Can you give some background on what Risk Evaluation and Mitigation Strategy (REMS) is and what are the best practices for working with therapies that have a REMS program?

What are the protocols that you have in place at your institution for therapies with a REMS program?

Zahra Mahmoudjafari explained that REMS programs are a Food and Drug Administration (FDA) mechanism designed to ensure that the safety risks associated with specific therapies are clearly communicated to prescribers, healthcare facilities, pharmacies, and patients, noting that each REMS program is unique and that BCMA-directed therapies currently carry REMS requirements for bispecific antibodies due to cytokine release syndrome (CRS) and neurotoxicity risks, and for belantamab mafodotin due to ocular toxicity, while the REMS programs previously required for CAR T-Cell therapies were recently removed. She outlined best practices including prescriber and facility certification, standardized patient education including wallet cards for patients who may present to outside centers, audit-ready program infrastructure, and minimizing administrative burden on frontline clinical teams by embedding REMS requirements into existing electronic medical record (EMR) workflows. Dr. Mahmoudjafari also described her institution's protocols, which include accessible policies in a centralized repository, treatment plans with built-in monitoring parameters, standardized management algorithms for CRS and immune effector cell-associated neurotoxicity syndrome (ICANS), tocilizumab availability protocols, and a health system-wide SharePoint site providing uniform patient education materials and outpatient step-up dosing recommendations to ensure consistency across all sites.

Throughout the conversation, the experts provided a comprehensive reflection on the field and the factors that may shape how clinicians approach care moving forward.

In the next episode, 'Adverse Event Management for Bispecific Antibodies and CAR T-Cell Therapies in Relapsed/Refractory Multiple Myeloma,' panelists continue their discussion on relapsed/refractory multiple myeloma and highlight the key adverse events associated with bispecific antibodies including the burden of CRS and ICANS on patients and healthcare settings, as well as the common adverse events observed with CAR T-Cell therapies and how they are monitored and managed.