FDA approval of Darzalex split dosing regimen- BMS

Genmab announced that FDA has approved a split dosing regimen for Darzalex (daratumumab). The approval will be included in an update to the Prescribing Information in order to provide healthcare professionals the option to split the first infusion of Darzalex over two consecutive days. The supplemental Biologics License Application (sBLA) was submitted by Genmab�s licensing partner, Janssen Biotech, Inc., in July, 2018.

The split dosing option was previously approved in Europe by the European Commission in December 2018. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

This approval was supported by data from the Phase Ib EQUULEUS (MMY1001) clinical trial, which demonstrated Darzalex pharmacokinetics (PK) concentrations were comparable regardless of whether the first dose was administered as a split infusion or as a single first infusion in patients with multiple myeloma. The safety profile of Darzalex was comparable when administered initially as either a split or a single dose. The Phase Ib EQUULEUS open-label study includes up to 240 patients with the goal of evaluating the safety, tolerability and dose of daratumumab when administered in combination with various backbone treatment regimens for different settings of multiple myeloma.