Johnson & Johnson has received a positive recommendation from the Committee for Medicinal Products for Human Use $(CHMP)$ for its drug DARZALEX® (daratumumab) as a treatment for patients with high-risk smouldering multiple myeloma. This endorsement sets the stage for potential European Commission approval, which would make daratumumab the first authorized treatment option for these patients. The recommendation is underpinned by data from the Phase 3 AQUILA study, demonstrating the drug's ability to significantly delay the onset of myeloma and extend overall survival. Johnson & Johnson has also submitted a supplemental Biologics License Application to the U.S. FDA for daratumumab's use in this new indication. If approved, it could offer a crucial new strategy for intercepting smouldering multiple myeloma before it progresses to active disease.