Janssen and Genmab's daratumumab fast-tracked by US FDA

Denmark-based biotech firm Genmab A/S (OMX: GEN) says that the US Food and Drug Administration has granted fast track designation for daratumumab (HuMax-CD38), which is being developed with Johnson & Johnson (NYSE: JNJ) subsidiary Janssen Biotech.

This designation covers 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 are double refractory to a PI and an IMiD.

“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,” said Jan van de Winkel, chief executive of Genmab.