Darzalex daratumumab regulatory update

Johnson & Johnson’s Janssen Biotech Inc. unit submitted an sBLA to FDA for Darzalex daratumumab in combination with Revlimid lenalidomide and dexamethasone or with Velcade bortezomib and dexamethasone to treat multiple myeloma (MM) in patients who have received >=1 prior therapy. Janssen requested Priority Review for the application. Darzalex has breakthrough therapy designation in the U.S. for the indication (see BioCentury, Aug. 8). ...