By Fineline Cube 
The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Johnson & Johnson’s (J&J, NYSE: JNJ) Darzalex (daratumumab) subcutaneous (SC) formulation as a monotherapy for adult patients with high-risk smoldering multiple myeloma (SMM). This recommendation, if approved, would make daratumumab the first therapy authorized for this specific patient population.
Condition Overview
Smoldering multiple myeloma (SMM) is an asymptomatic, intermediate stage of multiple myeloma characterized by detectable abnormal cells in the bone marrow. Current standard of care (SOC) for high-risk SMM patients involves active surveillance to monitor biochemical progression and signs of end-organ damage, with therapeutic intervention initiated only upon confirmed disease progression.
Significance of the Recommendation
The CHMP’s positive recommendation underscores the potential of daratumumab to address an unmet medical need. If approved, it would mark a significant advancement in the treatment landscape for SMM, offering a proactive therapeutic option before the disease progresses to active multiple myeloma.-Fineline Info & Tech