US-based biotechnology company Halozyme Therapeutics Inc (NASDAQ:HALO) announced on Wednesday that Janssen-Cilag International NV, a Johnson & Johnson (NYSE:JNJ) company, has received European Commission approval for a new indication for DARZALEX Faspro (daratumumab) co-formulated with ENHANZE, as monotherapy for the treatment of adult patients with smouldering 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. The current standard of care for SMM, even in high-risk cases, is active monitoring (or 'Watch and Wait') to track for signs of biochemical progression and/or end-organ damage. This means therapeutic intervention is only offered when the disease progresses.

The European Commission approval is supported by data from the Phase 3 AQUILA study, evaluating the efficacy and safety of fixed-duration monotherapy daratumumab SC compared with active monitoring in those with high-risk SMM.