Genmab Announces U.S. FDA Approval Of DARZALEX® (daratumumab) For Relapsed Multiple Myeloma And Updates Financial Guidance

Company Announcement
  • DARZALEX (daratumumab) approved by U.S. FDA in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for relapsed or refractory multiple myeloma
  • Financial guidance updated to include milestone payments totaling USD 65 million

Copenhagen, Denmark; November 21, 2016 - Genmab A/S (Nasdaq Copenhagen: GEN) announced today the U.S. Food and Drug Administration (FDA) has approved the use of DARZALEX ® (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.  In July 2016, daratumumab was granted a Breakthrough Therapy Designation (BTD) in this patient population.  In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize DARZALEX.

Genmab will receive milestone payments totaling USD 65 million from Janssen associated with the first commercial sale of the daratumumab in combination with lenalidomide and dexamethasone and in combination with bortezomib and dexamethasone in the United States.  As this will occur quickly after this approval, Genmab is improving its financial guidance for the year.  See the Outlook section of this announcement for more information.