On November 6, 2025, the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro (daratumumab and hyaluronidase-fihj, Janssen Biotech, Inc.) for the treatment of adults with high-risk smoldering multiple myeloma (SMM). This marks a significant step forward in addressing the pre-malignant stage of multiple myeloma.
AQUILA Trial (NCT03301220): Key Clinical Data
The approval is based on the AQUILA trial, an open-label, randomized study enrolling 390 patients with high-risk SMM. Patients in the treatment arm received Darzalex Faspro 1,800 mg/30,000 units subcutaneously once weekly (Weeks 1–8), every two weeks (Weeks 9–24), and then every four weeks for up to 36 months or until disease progression.
Efficacy: Prolonged Progression-Free Survival
The primary endpoint, progression-free survival (PFS), was not reached in the treatment arm compared to 41.5 months in the active monitoring arm (Hazard Ratio: 0.49 [95% CI: 0.36–0.67]; p<0.0001), showing a substantial risk reduction.
Safety and Warnings
The prescribing information for Darzalex Faspro includes warnings for hypersensitivity, cardiac toxicity (particularly in amyloidosis), infections, neutropenia, thrombocytopenia, embryo-fetal toxicity, and interference with blood compatibility testing.
Significance and Future Outlook
This approval introduces the concept of early immune intervention for high-risk SMM, potentially delaying or preventing progression to symptomatic multiple myeloma. The AQUILA trial results highlight how immunotherapy continues to reshape the continuum of care in plasma cell disorders.
This article was produced by the Morningglorysciences Editorial Team.
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