Janssen completes rolling submission of BLA to FDA for multiple myeloma drug daratumumab

The BLA for daratumumab is to treat MM patients who have received at least three 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.

In May 2013, the FDA granted a breakthrough therapy designation (BTD) for daratumumab in this population.

The completion of the BLA submission triggers a milestone payment of $15m to Genmab from Janssen.

Janssen Biotech secured an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab in August 2012.

Along with this BLA, a request for Priority Review has been submitted to the FDA by Janssen.

If daratumumab is approved by the FDA, Genmab will receive a milestone payment of $45m from Janssen associated with the first commercial sale of the product in the US.

Genmab chief executive officer Jan van de Winkel said: "The rapid completion of the BLA submission brings us a significant step closer to the potential regulatory approval of daratumumab.

"Daratumumab received Breakthrough Therapy Designation from the FDA for this indication for multiple myeloma patients who have no other treatment options available, and we are proud that our partner Janssen has completed the submission in record time."

The BLA submission is based on data from the Phase II trial (Sirius MMY2002) of daratumumab in MM patients who have received at least three prior lines of therapy including both a PI and an IMiD, or who are double refractory to a PI and an IMiD.

The submission also includes safety and efficacy data from the Phase I/II trial (GEN501) and safety data from three other studies.