Overview

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells.1 Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab.

A subcutaneous formulation of daratumumab, DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) has been approved by the U.S. FDA for certain multiple myeloma indications.

Indication and Safety

Daratumumab, marketed as DARZALEX®, is the first human CD38 monoclonal antibody to reach the market and the first monoclonal antibody (mAb) to receive the U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

In the U.S., side effects may be reported to the FDA at 1-800-FDA-1088. Patients in the U.S., E.U. and Japan can also contact the local Janssen Drug Safety Team about reporting side effects.

Clinical Studies

A comprehensive clinical development program for daratumumab is ongoing by Janssen.

Reference

De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. J Immunol. 2011;186:1840-1848.

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