Darzalex combination therapy approved in USA

The US Food and Drug Administration (FDA) has approved Darzalex (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 (PI).

Darzalex, which was discovered by Danish biotech Genmab (OMX: GEN) and is being developed in partnership with Janssen, the pharma arm of US healthcare giant Johnson & Johnson (NYSE: JNJ), is the first CD38-directed antibody approved anywhere in the world.

It was first given the green light by the FDA in November 2015 as a monotherapy treatment for patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent.