The European Commission (EC) has approved a new indication for daratumumab (Darzalex®) for the treatment of adult patients with smouldering myeloma (SMM) at high-risk of developing myeloma. This follows a positive recommendation from the Committee for Medicinal Product for Human Use (CHMP) in June 2025. The CHMP is the European Medicines Agency’s (EMA) committee playing a significant role in the assessment and authorisation of human medicines.

Daratumumab is a monoclonal antibody designed to recognise and bind to the CD38 protein, which is found on the surface of myeloma cells. By attaching to CD38, daratumumab kills myeloma cells. It also activates the immune system to find and kill more myeloma cells. The medicine is delivered subcutaneously (SC – i.e., through the skin) as monotherapy (i.e., on its own).

This is the first treatment regimen for smouldering myeloma. Pricing and reimbursement decisions will be taken at country level and therefore determine treatment availability.

If you have any questions or comments about the approval, please email info@mpeurope.org