Daratumumab: First Global Approval.

Daratumumab (Darzalex™) is a first-in-class, humanized IgG1κ monoclonal antibody that targets the CD38 epitope and was developed by Janssen Biotech and Genmab. Intravenous daratumumab was recently approved via an accelerated approval programme in the USA for patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. The drug is in preregistration for this indication in the EU and Canada. In a phase II trial in patients with previously treated (as described above) relapsed or refractory multiple myeloma, monotherapy with daratumumab 16 mg/kg achieved an overall response rate of approximately 30 %. This article summarizes the milestones in the development of daratumumab leading to this first approval for multiple myeloma.