Posted by Michael Wonder on 03 Sep 2018
Genmab announces European marketing authorisation for Darzalex (daratumumab) for front line multiple myeloma
31 August 2018 - Darzalex approved in Europe in combination with bortezomib, melphalan and prednisone in patients with newly diagnosed multiple myeloma.
Genmab announced today that the European Commission has granted marketing authorization for Darzalex (daratumumab) 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
The approval follows a positive opinion issued for Darzalex by the CHMP of the EMA in July 2018. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialise daratumumab.
