Posted by Michael Wonder on 17 Jun 2017
Genmab announces U.S. FDA approval of Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for relapsed or refractory multiple myeloma
16 June 2017 - Darzelax (daratumumab) approved by U.S. FDA in combination with pomalidomide and dexamethasone for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Genmab announced today the U.S. FDA has approved the use of Darzelax (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Darzalex is being developed under an August 2012 agreement in which Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialise the product. Genmab will receive milestone payments totaling USD 25 million from Janssen in connection with the approval and first commercial sale of Darzalex under the newly expanded label. The sale is expected to occur quickly after the approval.
