The Food and Drug Administration (FDA) has approved a split-dosing regimen for Darzalex (daratumumab; Janssen), which provides clinicians the option of splitting the first infusion of daratumumab over 2 consecutive days.
Darzalex, a CD38-directed cytolytic antibody, is indicated for the treatment of multiple myeloma. The approval was based on data from the Phase 1b EQUULEUS study which showed that regardless of whether the first dose was administered as a single or split infusion, pharmacokinetic (PK) concentrations were comparable at the end of weekly dosing.
Specifically, split dosing of the first dose resulted in a different PK profile in the first day compared to single dosing, however, similar concentrations were both predicted and observed following the administration of the second split dose on Week 1 Day 2. Splitting the first dose resulted in a similar rate and pattern of infusion reactions as compared with single infusion administration; a comparable safety profile was also observed between split and single infusion dosing.
“The first infusion of Darzalex is an important first step in a patient’s course of therapy, and this approval provides added flexibility for how patients may receive initial treatment,” said Craig Tendler, MD, Vice President, Clinical Development and Global Medical Affairs, Janssen Research & Development, LLC.
Darzalex is supplied as a 100mg/5mL or 400mg/20mL solution in single-dose vials.
For more information visit DarzalexHcp.com.