Daratumumab regulatory update

Johnson & Johnson’s Janssen Research & Development LLC unit began submission of a rolling BLA to FDA for daratumumab to treat multiple myeloma (MM) in patients who have received >=3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and an IMiD. The human mAb against CD38 has breakthrough therapy designation in the U.S. for the indication. ...