Overview
- Regulators approved subcutaneous daratumumab and hyaluronidase-fihj monotherapy for adults with high-risk smoldering multiple myeloma, the first therapy authorized for this condition.
- Approval rests on the Phase III AQUILA trial, where median progression-free survival was not reached with treatment versus 41.5 months with active monitoring (hazard ratio 0.49).
- Secondary outcomes favored therapy, including a higher overall response rate (63.4% vs 2%), improved five-year PFS (63.1% vs 40.7%), and longer time to first-line myeloma treatment.
- Safety findings showed more grade 3–4 adverse events with treatment (40.4% vs 30.1%), a 5.7% discontinuation rate due to events, and similar rates of treatment-related deaths (1% vs 2%).
- Experts say the decision may shift practice away from watch-and-wait for high-risk cases, though real-world uptake could be shaped by multi-year treatment, infection risk, monitoring needs, and payer controls.