Daratumumab Split-Dosing Regimen for Multiple Myeloma Approved by the FDA
Posted: Wednesday, February 13, 2019
The U.S. Food and Drug Administration (FDA) has approved a split-dosing regimen for daratumumab (Darzalex), a CD38-directed antibody, providing health-care professionals and patients with multiple myeloma an option to split the first infusion over 2 consecutive days. The approval is based on data from the phase Ib EQUULEUS (MMY1001) clinical study (ClinicalTrials.gov identifier NCT01998971), which demonstrated daratumumab pharmacokinetic concentrations were comparable at the end of weekly dosing, regardless of whether the first dose was administered as a split infusion or as a single infusion.
This global, multiarm study in multiple myeloma evaluated daratumumab in combination with various treatment regimens. Splitting the first dose of daratumumab over 2 consecutive days effectively reduced the duration of the first infusion and resulted in a similar rate and pattern of infusion reactions. Data from the study demonstrated that daratumumab concentrations were comparable at the end of weekly dosing, regardless of whether the first 16 mg/kg dose was administered as a split infusion or a single first infusion.
The safety profile of daratumumab was comparable when administered initially as a split or single dose, and no new safety events were observed with a split first dose.
This approval follows approvals in Canada and the European Union in December 2018 for the daratumumab initial infusion split-dosing regimen.
