Posted by Michael Wonder on 05 Jun 2020
Genmab announces European marketing authorisation for the subcutaneous formulation of Darzalex (daratumumab) for the treatment of patients with multiple myeloma
4 June 2020 - Approval based on data from Phase III COLUMBA and Phase II PLEIADES studies.
Genmab announced today that the European Commission has granted marketing authorization for the subcutaneous (SC) formulation of Darzalex (daratumumab), for the treatment of adult patients with multiple myeloma in all currently approved daratumumab intravenous (IV) formulation indications in frontline and relapsed refractory settings.
The approval follows a Positive Opinion by the CHMP of the EMA 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.
