, a monoclonal antibody treatment for newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant.
The current application is based on the randomized, multicenter, phase 3 ALCYONE study of daratumumab in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) in de novo multiple myeloma patients.
Priority review is an FDA designation for drugs that treat a serious condition and may provide a significant improvement in safety or efficacy. The agency has assigned the drug a Prescription Drug User Fee Act date of May 21, which is a target date for an approval decision.
Daratumumab is being developed by Janssen Biotech, in partnership with Genmab.