November 6, 2025—According to this press release, "the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adults with high-risk smoldering multiple myeloma (SMM)."

The AQUILA trial (NCT03301220) evaluated subcutaneous daratumumab and hyaluronidase-fihj (Darzalex Faspro®) versus active monitoring in 390 patients with high-risk smoldering multiple myeloma (SMM). Treatment significantly delayed progression to multiple myeloma, with median progression-free survival not yet reached compared to 41.5 months in the monitoring group (HR 0.49; p < 0.0001). Darzalex Faspro is approved only for high-risk SMM and carries warnings for hypersensitivity, cardiac toxicity, infections, cytopenias, embryo-fetal toxicity, and interference with blood typing. The recommended dose is 1,800 mg/30,000 units given subcutaneously over 3–5 minutes. 

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