FDA Approves Split-Dosing Regimen of Daratumumab for Multiple Myeloma

February 12, 2019 – The FDA has approved a split-dosing regimen of daratumumab for patients with multiple myeloma, providing physicians the option to split the first infusion of the CD38-directed monoclonal antibody over 2 consecutive days or complete in a single session. The approval is based on findings from the phase Ib EQUULEUS (MMY1001) trial, which demonstrated that the pharmacokinetic concentrations of daratumumab at 16 mg/kg were comparable at … (leggi tutto)