U.S. License Holder:
Date of License:
DARZALEX (daratumumab) is a CD38-directed cytolytic antibody indicated:
In combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant;
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 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;
As monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
U.S. Patent LitigationsPACER
U.S. Patent Nos.
8,263,746 (Anti-CD38 Human Antibodies and Uses Thereof) 9,200,061 (Generation and Profiling of Fully Human HuCAL Gold®-Derived Therapeutic Antibodies Specific for Human CD3I) 9,758,590 (Anti-CD38 Human Antibodies and Uses Thereof)
Genmab A/S; Genmab US, Inc.; Janssen Biotech, Inc.