Darzalex adds breakthrough designation for second-line MM

Genmab A/S (CSE:GEN) said FDA granted Darzalex daratumumab breakthrough therapy designation in combination with Revlimid lenalidomide and dexamethasone, or with Velcade bortezomib and dexamethasone, or with Velcade bortezomib and dexamethasone, as a second-line treatment for multiple myeloma.

The human IgG1k mAb against CD38 has accelerated approval from FDA to treat MM in patients who have failed at least three prior therapies, including a proteasome inhibitor (PI) and an immunomodulatory agent. Darzalex has breakthrough therapy designation in that indication as well. ...