Darzalex gets conditional European approval

The European Commission granted conditional approval to Darzalex daratumumab from Johnson & Johnson (NYSE:JNJ) to treat relapsed and refractory multiple myeloma (MM) in adults whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent.

The human IgG1k against CD38 has accelerated approval from FDA to treat MM patients who have received at least three prior therapies, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent. ...