Healthcare products company Johnson & Johnson (J&J) (NYSE:JNJ) announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smouldering multiple myeloma (HR-SMM).

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

This approval is based on findings from the AQUILA study that assessed 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. It demonstrated a significant improvement in the primary endpoint of progression-free survival (PFS), with the product decreasing the risk of disease progression to active multiple myeloma or death by 51% compared to active monitoring, according to the International Myeloma Working Group (IMWG) diagnostic criteria for multiple myeloma.

Peter Voorhees, MD, at the Atrium Health/Levine Cancer Institute in Charlotte, NC, said: "Until now, patients diagnosed with smouldering multiple myeloma only have the option to watch and wait for any active signs of progression to active disease. Results from AQUILA demonstrated DARZALEX FASPRO significantly delayed disease progression, underscoring the role of early disease intervention for patients with high-risk smouldering multiple myeloma."