Horsham : Johnson & Johnson has announced 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).

DARZALEX FASPRO is an approved treatment for HR-SMM, enabling earlier intervention before the disease progresses to active multiple myeloma .

FDA approval is based on findings from the AQUILA study ( NCT03301220), which evaluated the efficacy and safety of DARZALEX FASPRO compared to active monitoring (or “Watch and Wait”) in the largest Phase 3 trial in patients with HR-SMM. The AQUILA study demonstrated a significant improvement in the primary endpoint of progression-free survival (PFS), with DARZALEX FASPRO reducing the risk of dise

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