FDA approves monthly Elrexfio dosing regimen based on long-term MagnetisMM-3 data

In June 2025, the FDA approved a revised dosing schedule for Elrexfio (elranatamab) allowing for every-4-week maintenance dosing following the initial step-up and weekly induction phase. This change was supported by long-term data from the MagnetisMM-3 study, which demonstrated that monthly dosing sustained response rates and provided a favorable safety and convenience profile. Patients receiving the extended interval experienced fewer clinic visits, enhancing treatment adherence and reducing healthcare utilization. Clinicians welcomed the change as a significant improvement for patient quality of life and management in outpatient settings. This label update distinguishes Elrexfio from other BCMA bispecifics still requiring more frequent administration, potentially giving it a competitive advantage in the commercial landscape. The approval reflects growing emphasis on convenience and chronic disease management in multiple myeloma.‍

Citation: https://www.empr.com/news/fda-approves-new-dosing-regimen-for-elrexfio-in-r-r-multiple-myeloma/

Implication: Supports broader use of Elrexfio through improved convenience and potentially better adherence.

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