31 May 2016 - The EMA has published an EPAR for daratumumab (Darzalex).

The European Commission approved Darzalex on 20 May 2016 for use as as monotherapy is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.

Darzalex will be subjected to additional monitoring by the EMA.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004077/human_med_001979.jsp&mid=WC0b01ac058001d124