Genmab has announced that the Food and Drug Administration (FDA) has approved the use of DARZALEX (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies.
The approval was based on the results of the Phase I study, EQUULEUS, which assessed the combination therapy for the treatment of relapsed or refractory multiple myeloma.
“We are very pleased to receive the FDA’s decision to approve DARZALEX in combination with pomalidomide and dexamethasone,” said Jan van de Winkel, PhD, chief executive officer of Genmab. “This offers another alternative to patients with multiple myeloma who haven’t seen lasting effects from other types of treatment.”
Development of the therapy was arranged in 2012 when an exclusive worldwide license for the development and commercialisation of daratumumab was agreed upon by Genmab and Janssen Biotech. Under the terms of this previous agreement, Genmab will receive a milestone payment of $25 million from Janssen in connection with the approval and first commercial sale of the drug under the newly expanded label.