Almost four months ahead of the FDA Prescription Drug User Fee Act (PDUFA) goal date of March 9, 2016, the agency granted accelerated approval to Genmab A/S's anti-CD38 multiple myeloma antibody Darzalex (daratumumab) injection, administered as a single agent for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a PI and an IMiD agent.