European Commission approves split dosing regimen for Darzalex for treatment of multiple myeloma. Genmab + Janssen

Genmab A/S announced today that the European Commission (EC) has granted marketing authorization for a split dosing regimen for Darzalex (daratumumab). The approval will be included in an update of the Summary of Product Characteristics in order to provide health care professionals the option to split the first infusion of Darzalex over two consecutive days.

The EC approval follows a positive opinion issued for Darzalex by the European Committee for Medicinal Products for Human Use (CHMP) on 18th November 2018. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab. This approval was based on 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. About the EQUULEUS (MMY1001) .