New BLA for Genmab's multiple myeloma med Darzalex submitted to FDA

A supplemental Biologics License Application (sBLA) has been submitted to the US Food and Drug Administration (FDA) for the use of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who received at least one prior therapy.

Only last month daratumumab was granted a breakthrough therapy designation (BTD) in this patient population.

The treatment is being developed by Janssen Biotech, a subsidiary of US healthcare giant Johnson & Johnson (NYSE: JNJ), under an exclusive worldwide license from Danish biotech firm Genmab (OMX: GEN). The submission of the application triggers milestone payments totaling $15 million to Genmab from Janssen.