Posted by Michael Wonder on 06 Nov 2025
FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myeloma
6 November 2025 - On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) for adults with high-risk smoldering multiple myeloma.
Efficacy of daratumumab and hyaluronidase-fihj as monotherapy versus active monitoring was evaluated in AQUILA, an open-label, randomized trial in 390 patients with high-risk smoldering multiple myeloma.
