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Janssen Submits BLA to FDA

Genmab A/S’s licensing partner Janssen Biotech, Inc. has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for daratumumab for double refractory multiple myeloma.

 The submission is for using daratumumab to treat patients with multiple myeloma who have received at least three different lines of therapy including both a proteasome inhibitor and an immunomodulatory agent (IMiD), or who are double refractory to a proteasome inhibitor and an IMiD, according to Genmab.  A rolling submission allows completed portions of an application to be submitted to the FDA on an ongoing basis.  This type of review is granted by the FDA if the agency determines after a preliminary evaluation of clinical data that the breakthrough therapy may be effective. Daratumumab received a Breakthrough Therapy Designation (BTD) for this indication from the FDA in May 2013.

 In August 2012, Genmab and Janssen Biotech, Inc. entered an agreement that provided Janssen a worldwide exclusive license to develop, manufacture and commercialize daratumumab. Janssen currently is the sponsor of all but one study globally.

The submission includes data from the Phase II study of daratumumab in multiple myeloma patients who have received at least three prior lines of therapy including both a proteasome inhibitor and an IMiD or who are double refractory to a proteasome inhibitor and an IMiD.  Safety and efficacy data from the Phase I/II study (GEN501) and safety data from three other studies, also have been included in the BLA submission. 

“Daratumumab is a highly innovative antibody that holds promise for patients with multiple myeloma, a disease for which there is currently no cure.  Today, patients that are double refractory have run out of treatment options and we are very pleased that daratumumab offers the potential to help this group of patients. The initiation of this rolling BLA submission is a landmark in the development of daratumumab and we are working together with Janssen to bring this new treatment option to patients as quickly as we can,” said Jan van de Winkel, Ph.D., chief executive officer of Genmab.

 Source: Genmab