EMA recommends a new indication for daratumumab in adult patients with newly diagnosed myeloma who are eligible for autologous stem cell transplant
On 19 September the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a new indication for daratumumab (Darzalex®, commercialised by Janssen). The new indication is a combination of daratumumab, bortezomib, lenalidomide and dexamethasone and it brings a significant benefit with respect to progression-free survival compared to…