Janssen R&D Granted Breakthrough Therapy Designation for Daratumumab
Janssen Research & Development announced that the FDA granted daratumumab Breakthrough Therapy Designation for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and IMiD.
Daratumumab is an investigational human monoclonal antibody (mAb) with broad spectrum cytotoxic activity. It targets the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. It may also demonstrate potential in other cancers on which CD38 is expressed.
Daratumumab is currently in Phase 1/2 trials for multiple myeloma.For more information visit www.janssenrnd.com.