Daratumumab subcutaneous, first approved treatment for newly diagnosed AL amyloidosis in Europe
The European Commission (EC) has granted marketing authorisation for the expanded use of daratumumab (Darzalex®) subcutaneous (SC) formulation in two new indications. The first authorisation of these new indications is for the use of daratumumab SC in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adults with newly diagnosed systemic light chain (AL) amyloidosis. This approval makes this daratumumab-based regimen the first approved therapy for AL amyloidosis in Europe.