On November 21, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that Janssen Pharmaceutica NV (Janssen) has submitted a Type II variation application to the European Medicines Agency (EMA) (Press release, Genmab, NOV 21, 2017, View Source [SID1234522194]). This application seeks to broaden the existing marketing authorization for daratumumab (DARZALEX) to include use in combination with bortezomib, melphalan and prednisone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The submission of the application triggers milestone payments totaling USD 3 million to Genmab from Janssen. The milestone payments were included in Genmab’s financial guidance for 2017, which was published on November 14, 2017. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
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"We are very pleased about this submission, which marks the first application for the use of daratumumab for patients with newly diagnosed multiple myeloma. We look forward to working with both Janssen and the EMA so that daratumumab can potentially become available for a broader group of multiple myeloma patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
The submission is based on data from the Phase III ALCYONE study of daratumumab in combination with bortezomib, melphalan and prednisone in front line multiple myeloma. This data will also be used as the basis for a potential regulatory submission to the U.S. Food and Drug Administration.