The subcutaneous formulation of Darzalex (daratumumab) was granted marketing approval by the European Commission for the treatment of adult patients with multiple myeloma in all currently approved daratumumab intravenous formulation indications in frontline and relapsed / refractory settings.
Darzalex is sponsored by Genmab. In August 2012, Genmab granted Janssen Biotech Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
The approval follows a Positive Opinion by the CHMP of the European Medicines Agency in April 2020. The SC formulation is administered as a fixed-dose over approximately three to five minutes, significantly less time than IV daratumumab, which is given over several hours.
Patients currently on daratumumab IV will have the choice to switch to the SC formulation.
The approval was based on data from two studies: the phase III non-inferiority COLUMBA (MMY3012) study, which compared the SC formulation of daratumumab to the IV formulation in patients with relapsed or refractory multiple myeloma, and data from the Phase II PLEIADES (MMY2040) study, which is evaluating SC daratumumab in combination with certain standard multiple myeloma regimens.
