Navigating REMS: Challenges, Perspectives, and the Path Forward for Bispecific Antibody Programs

This episode, titled 'Navigating REMS: Challenges, Perspectives, and the Path Forward for Bispecific Antibody Programs,' features oncology pharmacists discussing the following critical question:

Recent evidence found that pharmacists expressed confidence in managing CRS and ICANS. However, REMS requirements and step-up dosing logistics remain as ongoing operational challenges. Where exactly does the friction live in your experience?

Led by the moderator, the panelists offered candid perspectives on the REMS programs associated with myeloma bispecific antibodies, with one panelist framing them as a logistical burden that may have been modeled after the more intensive safety requirements of CAR-T therapy, where CRS and neurotoxicity severity is considerably higher, and noting that the absence of REMS requirements for lymphoma bispecifics with comparable adverse event profiles raises questions about whether myeloma products have been disproportionately burdened. The discussion also surfaced a more nuanced view, with another panelist acknowledging that REMS programs provided a structured platform to drive physician education and institutional accountability in the early rollout of these therapies in community settings while still expressing frustration with portal design limitations that do not accommodate centralized management across dozens of infusion centers and with audit processes that sometimes impose requirements beyond what the program actually mandates. The panelists ultimately found common ground in their hope that REMS requirements for myeloma bispecifics will be simplified or reduced as clinical experience matures and provider confidence in CRS and neurotoxicity management becomes more widespread.

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

The next episode in this series, 'Pharmacists at the Center: Managing REMS Education, Compliance, and Collaboration Across Care Settings,' features the panelists advancing their conversation on multiple myeloma and focusing on the central role pharmacists play in coordinating REMS education, ensuring ongoing compliance, and driving cross-team communication and how institutions of different sizes and structures are scaling this responsibility to ensure that every provider, nurse, and support staff member is prepared before a bispecific antibody program goes live.