Supplemental BLA Submitted for Darzalex Split Dosing Regimen

Janssen has submitted a supplemental Biologics License Application (sBLA) to the Food and Drug Administration (FDA) seeking approval of a split dosing regimen for Darzalex (daratumumab), a CD38-directed cytolytic antibody indicated for the treatment of multiple myeloma. 

The proposed dosing regimen would provide the option of splitting the first infusion of Darzalex over 2 consecutive days. The sBLA submission was based on preliminary results from a Phase 1b study (MMY1001) assessing Darzalex in combination with various treatment regimens. The Company states that early results demonstrated that Darzalex concentrations were comparable after administration of the first dose regardless of whether it was administered as a split infusion or single first infusion. Additionally, no new safety events were observed in the split-dose group. 

“We look forward to reviewing the data in support of these applications with regulators and hope to make a Darzalex split-dose option available to patients and healthcare professionals to provide additional flexibility in administration of the initial infusion,” said Craig Tendler, MD, VP, Janssen R&D.

For more information visit Janssen.com.