According to a press release from Johnson & Johnson, "the European Commission (EC) has approved an indication extension of DARZALEX® (daratumumab) subcutaneous (SC) formulation in the frontline setting. The approval is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma (NDMM)."

This approval is based on results of the phase III CEPHEUS trial, which "evaluated the efficacy and safety of daratumumab-VRd (n=197) compared to VRd (n=198) for patients with NDMM who are transplant ineligible or for whom autologous stem cell transplant (ASCT) was not planned as initial therapy (transplant ineligible or deferred)." Read the full press release from the button below.