The European Commission has granted marketing authorisation for DARZALEX® (daratumumab) as a monotherapy treatment for adults with high-risk smouldering multiple myeloma. This marks the first approved treatment in the European Union for this specific stage of the disease.
First EU Approval for High-Risk Smouldering Myeloma
Darzalex Subcutanese (SC) formulation is now authorized for patients who solve many myeloma who are at high risk of progression for active disease. Soltana Myelom is a touching stage where abnormal plasma cells are already present in the bone marrow.
So far, doctors had no approved treatment for this group, and often trust active monitoring alone. This approval offers a new alternative aimed at delaying or preventing progress.
The Aquila study confirms clinical benefits
The decision from the EU Commission follows the data from Phase 3 Aquila study. The test consisted of 390 patients and compared Darutumumab SC with active monitoring. Among patients receiving treatment, 63.1 percent remained alive and progress -free in five years, compared with 40.8 percent in the control group.
The treatment for those defined as high-risk using Mayo 2018 criteria did not lead to progress-free existence in the treatment, while it was 22.1 months for active monitoring. The risk of progress or death was reduced by a total of 51 percent.
The survival rate for five years was also higher with Darratumumb SC: 93.0 per cent compared to 86.9 per cent for active monitoring.
Strong security profiles and reaction rates
Darzalex showed a steady security profile with previous uses in many myeloma. Grade 3 or 4 remedies-free side effects occurred in 40.4 per cent of patients in the treatment group and 30.1 per cent in the control group.
The most common side effects were high blood pressure. Only 5.7 percent of patients in the treatment group were discontinued due to unfavorable events. In the control group, 1.0 per cent of treatment patients led to 2.0 per cent to deadly incidents.
The overall response rate in the treatment arm was 63.4 percent, far higher than the 2.0 percent seen in the active monitoring arm. Median time to first-line therapy was not reached in the DARZALEX group, compared to 50.2 months for control.
A New Chapter in Early Myeloma Care
Smouldering multiple myeloma accounts for about 15 percent of newly diagnosed myeloma cases. Around half of high-risk patients progress to active disease within two years. Previously, these patients had no approved options to intervene before symptoms emerged.
This approval now gives doctors a regulatory-cleared treatment tool to address disease earlier in the course. It may also help reduce irreversible damage and improve long-term patient outcomes.
DARZALEX Background and Impact
DARZALEX is a CD38-directed antibody therapy. It works by targeting myeloma cells and triggering cell death. The subcutaneous formulation uses Halozyme’s ENHANZE® technology. Since its launch, DARZALEX has been used by more than 618,000 patients worldwide.
This approval reflects Johnson & Johnson’s focus on expanding treatment options for multiple myeloma at every stage. With this latest indication, DARZALEX becomes the first authorised intervention for high-risk smouldering myeloma in Europe.
DARZALEX high-risk smouldering multiple myeloma is now part of the European treatment landscape, offering patients and physicians a new path forward.