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FDA Approves Darzalex Faspro as First Therapy for High-Risk Smoldering Multiple Myeloma

The ruling follows a Phase 3 trial that cut the risk of progression or death by 51% versus active monitoring.

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Johnson & Johnson's star oncology drug, Darzalex Faspro, has gained approval from the FDA in smouldering multiple myeloma, marking an indication first. Image credit: Kyle Grillot / Bloomberg via Getty Images.
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Overview

  • Adults with high-risk smoldering disease can now receive subcutaneous daratumumab/hyaluronidase at 1,800 mg/30,000 units administered over 3 to 5 minutes.
  • The Phase 3 AQUILA trial randomized 390 patients and, after a 65.2‑month median follow‑up, showed median PFS not reached with treatment versus 41.5 months with monitoring.
  • Five-year PFS was 63.1% with Darzalex Faspro versus 40.7% with monitoring, and the overall response rate was 63.4% versus 2.0%.
  • Treatment delayed the start of first-line multiple myeloma therapy (median not reached vs 50.2 months), and an analysis reported an overall survival hazard ratio of 0.52.
  • Grade 3–4 adverse events occurred in 40.4% on therapy versus 30.1% with monitoring, with 5.7% discontinuing treatment; analysts say uptake may hinge on strict high‑risk criteria, careful monitoring, and payer controls as J&J expands a key franchise.