Genmab Announces Submission of Supplemental Biologics License Application to FDA for Daratumumab in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontline Multiple Myeloma
GENMAB A/S (GMXAY)
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ir.genmab.com
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Source: GlobeNewswire
Company Announcement sBLA submitted to U.S. FDA 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 transplantSubmission based on data from Phase III CASSIOPEIA study Copenhagen, Denmark; March 26, 2019 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its licensing partner, Janssen Biotech, Inc., has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (U.S. FDA) for the use of daratumumab (DARZALEX®) 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). In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab. “This application is an important step in potentially providing a new group o
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