The labeling for daratumumab (Darzalex, Janssen Pharmaceutical) has been revised by the FDA to allow a split-dosing regimen, providing health care professionals and patients with multiple myeloma an option to divide the first infusion over two consecutive days.
The decision was based on data from the phase 1b EQUULEUS (MMY1001) clinical trial, which demonstrated that daratumumab pharmacokinetic (PK) concentrations were comparable at the end of weekly dosing, regardless of whether the first