REMS Programs for BCMA-Directed Therapies: Background, Best Practices, and Institutional Protocols
ByRyan Haumschild, PharmD, MS, MBA, CPEL ,Zahra Mahmoudjafari, PharmD, MBA, BCOP, FHOPA,Al-Ola Abdallah, MD,Anjulie Quick, MD 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.