On November 6, 2025, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adults with high-risk smoldering multiple myeloma (SMM).1 Darzalex Faspro is only indicated for patients with high-risk SMM. It is not indicated for other risk categories.
Efficacy of daratumumab and hyaluronidase-fihj as monotherapy versus active monitoring was evaluated in AQUILA (NCT03301220), an open-label, randomized trial in 390 patients with high-risk SMM. Median progression-free survival was not evaluable in the daratumumab and hyaluronidase-fihj arm and 41.5 months in the active monitoring arm (hazard ratio, 0.49; 95% CI, 0.36-0.67; P<.0001).
The recommended dose is 1800 mg/30,000 units (1800 mg daratumumab and 30,000 units hyaluronidase) administered subcutaneously over 3 to 5 minutes.
The prescribing information for daratumumab and hyaluronidase-fihj includes warnings and precautions for hypersensitivity and other administration reactions, cardiac toxicity in patients with light chain amyloidosis, infections, neutropenia, thrombocytopenia, embryo-fetal toxicity, and interference with cross-matching and red blood cell antibody screening.
Reference
- US Food and Drug Administration. FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myeloma. Accessed November 6, 2025. www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-high-risk-smoldering-multiple-myeloma