Johnson & Johnson (NYSE:JNJ) announced Wednesday that the European Commission has granted approval for its Darzalex subcutaneous formulation to be used as a monotherapy for adults diagnosed with high-risk smouldering multiple myeloma.
This approval represents the first treatment option available for this patient group, addressing a significant unmet need in managing the asymptomatic, intermediate stage of the disease where abnormal plasma cells are detected in the bone marrow.
Professor Meletios A. Dimopoulos from the National and Kapodistrian University of Athens School of Medicine highlighted that “50 percent of high-risk patients progress to active multiple myeloma within two years,” and said the new approval “offers potential to change this trajectory.”
The decision was supported by results from the Phase 3 AQUILA study, which demonstrated that patients treated with Darzalex experienced notably better progression-free survival compared to those under active surveillance. At the 60-month mark, 63.1% of patients in the Darzalex group remained alive without disease progression, versus 40.8% in the monitoring group.
In addition, overall survival improved with Darzalex treatment, showing a 5-year survival rate of 93.0% compared to 86.9% for patients monitored without treatment. The overall response rate was also higher at 63.4% versus 2.0% in the monitoring arm.
The safety profile observed was consistent with previous clinical trials. Grade 3/4 treatment-related adverse events occurred in 40.4% of patients receiving Darzalex compared to 30.1% of those monitored. The most frequent serious adverse event reported was hypertension.
Ester in ’t Groen, EMEA Therapeutic Area Head Haematology at Johnson & Johnson Innovative Medicine, stated that “eligible patients no longer have to wait for progression without active treatment, instead having the option to intercept the disease with therapeutic intervention.”