European Commission Approves First Treatment for High-Risk Smoldering Multiple Myeloma

July 23, 2025—According to a press release from Johnson & Johnson, "the European Commission (EC) has approved a new indication for Darzalex® (daratumumab) subcutaneous (SC) formulation as monotherapy for the treatment of adult patients with smoldering multiple myeloma (SMM) at high-risk of developing multiple myeloma." SMM is an asymptomatic intermediate disease state of multiple myeloma where abnormal cells can be detected in the bone marrow. This approval marks a major milestone for patients with this early stage of myeloma, which often progresses to active disease within two years. Until now, doctors had no approved treatments for SMM and could only monitor these patients.

The approval is based on results from the phase III AQUILA trial, which showed that Darzalex significantly delayed disease progression. After five years, over 63% of patients treated with daratumumab were still progression-free, compared to about 41% in the observation group. The treatment also improved overall survival and delayed the need for more intensive therapy.

Darzalex showed a manageable safety profile, with few patients stopping treatment due to side effects. This new option gives patients and their doctors a way to act earlier and potentially prevent irreversible damage and symptoms from developing. To learn more about this new indication for Darzalex, read the full press release from the button below.