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Stock impact report

Genmab Announces European Regulatory Submission for Daratumumab in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontline Multiple Myeloma

GENMAB A/S (GMXAY) 
NASDAQ:AMEX Investor Relations: ir.genmab.com
Company Research Source: GlobeNewswire
Company Announcement Type II variation application submitted to the EMA for daratumumab in combination with bortezomib, thalidomide and dexamethasone as treatment for newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant Submission based on data from Phase III CASSIOPEIA study Copenhagen, Denmark; March 27, 2019 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Janssen Pharmaceutica NV (Janssen) has submitted a Type II variation application to the European Medicines Agency (EMA). This application seeks to broaden the existing marketing authorization for daratumumab (DARZALEX®) to include use in combination with bortezomib, thalidomide and dexamethasone (VTD) as treatment for newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant (ASCT). The submission is based on data from the Phase III CASSIOPEIA study of daratumumab in combination with VTD as frontline treatment for patients wit Show less Read more
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