Biotechnology company Genmab has obtained FDA fast track designation in double refractory multiple myeloma for daratumumab.
As per the designation, the human CD38 monoclonal antibody Daratumumab is suitable for multiple myeloma patients who were administered with three previous therapy lines such as a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or are double refractory to a PI and an IMiD.
Genmab chief executive officer Jan van de Winkel said, "Fast Track designation for daratumumab means that the FDA recognizes the potential of daratumumab to fill an unmet medical need in multiple myeloma, and that we may be able to reduce the development time and expedite review of the product."
In August 2012, Janssen Biotech gained exclusive worldwide license for the development and commercialization of daratumumab from Genmab.
