Photo: fda.gov
FDA Greenlights Darzalex Faspro for High-Risk Smoldering Myeloma Patients
The Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adults with high-risk smouldering myeloma, marking a significant advancement in treatment options.
- On November 6, 2025, the Food and Drug Administration granted approval for daratumumab and hyaluronidase-fihj (Darzalex Faspro) specifically targeting high-risk smouldering myeloma patients.
- The efficacy of daratumumab was assessed in the AQUILA trial, involving 390 patients, comparing its effectiveness as monotherapy against active monitoring for high-risk smouldering myeloma.
- This approval by the Food and Drug Administration is particularly crucial as high-risk smouldering myeloma can lead to symptomatic multiple myeloma, emphasizing the importance of early intervention.
Why It Matters
This approval is significant as it provides a new treatment option for high-risk smouldering myeloma patients, potentially improving progression-free survival and altering the course of the disease before it develops into symptomatic multiple myeloma.