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Investing.com -- Johnson & Johnson (NYSE:JNJ) announced Wednesday that the European Commission has approved its Darzalex subcutaneous formulation as a monotherapy for adults with high-risk smouldering multiple myeloma.
This marks the first approved treatment for this patient population, addressing an unmet clinical need for those with the asymptomatic intermediate disease state where abnormal cells can be detected in bone marrow.
Professor Meletios A. Dimopoulos of the National and Kapodistrian University of Athens School of Medicine noted that 50 percent of high-risk patients progress to active multiple myeloma within two years, and the approval offers potential to change this trajectory.
The approval was based on the Phase 3 AQUILA study, which showed patients receiving Darzalex had significantly improved progression-free survival compared to those under active monitoring. At 60 months, 63.1 percent of patients in the Darzalex arm remained alive and progression-free versus 40.8 percent in the monitoring arm.
Overall survival was also extended with Darzalex, with 5-year survival rates of 93.0 percent compared to 86.9 percent for active monitoring. Patients receiving the drug saw a higher overall response rate of 63.4 percent versus 2.0 percent with monitoring.
The safety profile was consistent with previous studies, with Grade 3/4 treatment-emergent adverse events occurring in 40.4 percent of treated patients compared to 30.1 percent of monitored patients. The most common Grade 3/4 adverse event was hypertension.
Ester in ’t Groen, EMEA Therapeutic Area Head Haematology at Johnson & Johnson Innovative Medicine, said eligible patients no longer have to wait for progression without active treatment, instead having the option to intercept the disease with therapeutic intervention.
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