The Food and Drug Administration has granted priority review for daratumumab, 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.
At a median follow-up of 16.5 months, there was a 50% reduction in the risk of progression or death in patients treated with daratumumab plus VMP, according to data presented at the annual meeting of the American Society of Hematology.
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.
