daratumumab

Ligand id: 7395

Name: daratumumab

No information available.
Summary of Clinical Use
This monoclonal antibody has been granted orphan drug approval in the EU (EMA 2013) for the treatment of plasma-cell myeloma, a rare form of white blood cell cancer. This antibody is in clinical trial for the treatment of other CD38-positive hematological malignancies including multiple myeloma. Click here to link to ClinicalTrials.gov's listing of daratumumab trials. In November 2015, the US FDA granted accelerated approval for daratumumab as a treatment for multiple myeloma, in patients who have received at least three prior treatments.
Phase III trial NCT02136134 evaluated the addition of daratumumab to bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma. Preliminary results suggest this combination is much more effective than the current standard of care (as presented at the 2016 ASCO Annual Meeting, June 3-7, Chicago: Abstract LBA4 and reported in [5]). In November 2016, the US FDA approved the use of daratumumab plus lenalidomide and dexamethasone, or bortezomib and dexamethasone for multiple myeloma patients who have received at least one prior therapy.
Mechanism Of Action and Pharmacodynamic Effects
Daratumumab binds the cell surface glycoprotein, CD38, which is highly expressed in hematological malignancies including multiple myeloma. Antibody/CD38 association induces cytotoxic events that lead to death of the malignant cells, in vitro and in vivo [2]. This antibody may improve the antineoplastic activity of other chemotherapy drugs used to treat myeloma [3-4].