24 May 2016 - Genmab announced today that the European Commission has granted a conditional marketing authorization for first-in-class CD38 antibody Darzalex (daratumumab).

The conditional approval is for the use of Daralex as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.

The European Commission approval follows a positive opinion issued for Darzalex by the CHMP of the EMA in April 2016. Conditional marketing authorizations are granted by the EMA for medicines where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Darzalex is the first human CD38 monoclonal antibody approved in Europe. The European approval follows the November 2015 U.S. FDA approval of Darzalex for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.

In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize Darzalex.

For more details, go to: http://ir.genmab.com/releasedetail.cfm?ReleaseID=972283