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Genmab submits FDA application for Daratumumab

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Genmab has announced that its licensing partner, Janssen Biotech, Inc. has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the use of daratumumab (DARZALEX) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who received at least one prior therapy.

In July 2016, daratumumab was granted a Breakthrough Therapy Designation (BTD) in this patient population.  The submission of the application triggers milestone payments totaling USD 15 million to Genmab from Janssen.  The milestone payments were included in Genmab’s financial guidance for 2016 that was published on August 9, 2016.  In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

“We are thrilled that an application to expand the current label to include treatment of multiple myeloma patients who received at least one prior therapy has been submitted so soon after the initial FDA approval of daratumumab in November 2015.  The data from the Phase III CASTOR and POLLUX studies on which the submission is based was unprecedented, meriting a Breakthrough Therapy Designation from the FDA. We believe that if approved, daratumumab has the potential to make a substantial positive impact in the treatment of patients with multiple myeloma who have relapsed on their previous therapy,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

A request for Priority Review has been submitted by Janssen with this sBLA. The FDA will inform Janssen whether a Priority Review has been granted by calendar day 60 of their review starting today. If the FDA grants Priority Review, the review should be completed within 6 months from today.

The submission includes data from two Phase III studies: the CASTOR study of daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma, and the POLLUX study of daratumumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma. The submission also included data from the Phase I study of daratumumab in combination with pomalidomide and dexamethasone in relapsed or refractory multiple myeloma.  These data will also be used as the basis for a potential regulatory submission to the European Medicines Agency (EMA).