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

1. FDA approved daratumumab and hyaluronidase for high-risk smoldering multiple myeloma. 2. Approval date: November 6, 2025. 3. AQUILA trial had 390 patients. 4. Significant improvement in progression-free survival compared to monitoring. 5. Specific dosing schedule includes subcutaneous administration weekly for the first 8 weeks. 6. Safety warnings include cardiac toxicity and hypersensitivity reactions. 7. Not indicated for other risk categories.