Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). This marks the first and only FDA-approved treatment for HR-SMM, allowing for earlier intervention before disease progression to active multiple myeloma. The approval is based on results from the Phase 3 AQUILA study, which demonstrated that DARZALEX FASPRO® significantly reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring.