FDA Approves Daratumumab and Hyaluronidase-fihj for High-Risk Smoldering Multiple Myeloma

The U.S. FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adults with high-risk smoldering multiple myeloma on November 6, 2025. This approval was based on the AQUILA trial, which randomized 390 patients to assess the efficacy of the treatment against active monitoring. Patients receiving the treatment displayed a significant progression-free survival advantage compared to the control group. The therapy is specifically indicated for high-risk patients, with specific dosing and important safety information outlined in the prescribing information.