Daratumumab regulatory update

Genmab said Johnson & Johnson’s Janssen Biotech Inc. unit completed submission of a rolling BLA to FDA for daratumumab to treat patients with multiple myeloma (MM) who have received >=3 prior lines of therapy, including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and an IMiD. Janssen requested Priority Review for the application. The completion of the submission triggered a $15 million milestone payment to Genmab from Janssen under a 2012 deal granting Janssen exclusive, worldwide rights to the human mAb against CD38 (see BioCentury, Sept. 3, 2012).

Daratumumab has breakthrough therapy designation in the U.S. for the indication. Janssen said the BLA is primarily supported by data from the Phase II Sirius MMY2002 trial, along with data from 4 other studies, including the Phase I/II GEN501 trial of daratumumab as a monotherapy (see BioCentury, June 8). ...