8 August 2018 - Applications seek to update prescribing information and summary of product characteristics.

Genmab announced today that its licensing partner, Janssen Biotech, has submitted a supplemental biologics license application to the U.S. FDA and a Type II variation to the EMA seeking approval of a split dosing regimen for Darzalex (daratumumab). The applications request to update the Prescribing Information and Summary of Product Characteristics in order to provide health care professionals the option of splitting the first infusion of Darzalex over two consecutive days. 

The submissions are 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. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialise daratumumab.

Read Genmab press release