Daratumumab & Multiple Myeloma (MM) / Plasmocytoma

Approval status

Daratumumab is approved by both the FDA and EMA for the treatment of multiple myeloma. However, there is no specific approval for its use in plasmacytoma as a separate indication (1)

In November 2015, the FDA granted accelerated approval for daratumumab as a monotherapy for patients with heavily pretreated multiple myeloma. The approval was later expanded to include multiple combination regimens for both relapsed and newly diagnosed multiple myeloma. More recently, the FDA approved additional regimens, including daratumumab and hyaluronidase-fihj with VRd, specifically for adults with newly diagnosed multiple …